Job Description

The Senior Account Manager (SAM) oversees projects within a vertical account team to ensure quality and provide continuity and tactical alignment while also leading high-profile projects from the client through to the project manager and cross-functional team. The SAM will partner with the Account Director to assist brand partners with the development and management of the tactical plan. This role requires a strong awareness of the account’s strategic direction, as well as knowledge of clients’ products and processes. The success of this position relies on the success of the team, meeting clients’ expectations, partnering with Avant colleagues, and individual performance. 

What you’ll do:

• Ensure quality and consistency across multiple tactics that are led by both Avant and   external partners  

• Provide oversight and consultation to Account Managers as it relates to project execution  

• Act as the in-house client at all times by communicating client expectations to the crossfunctional team  

• Act as the Customer Management Office (CMO) liaison within the respective   account (vertical)  

• Provide invoicing information and budget status updates to clients as requested  

• Provide direction and review job scope changes and closeouts as necessary  

• Provide peer-to-peer channel insights and recommendations  

• Drive strategic partnerships with clients by having and applying knowledge of their products and objectives  

• Lead and actively participate in strategic brainstorming sessions and annual   strategic planning  

• Assist the business owner as needed with the following tasks  

• Create proposals for projects within assigned accounts  

• Partner with finance team and project managers in budget development  

• Perform other strategic work as delegated by the Account Director

• Ensure strategic objectives are met with each client project  

• Support organic growth opportunities for the account through a strong understanding of Avant capabilities, client needs, and attention to buying signals  

• Partner successfully with Project Management Team to execute projects from the initiating and planning phases through the closing phase  

• Develop and manage project creative briefs and client scope statements  

• Supervise projects to ensure tactical and strategic goals are met  

• Follow all policies, procedures, industry standards, and compliance guidelines and ensure team members’ adherence  

• Execute client status meetings and prepare all meeting materials and follow-up items (agendas, notes, etc.)  

• Partner successfully with Project Management Team to execute projects from the initiating and planning phases through the closing phase (cont.)  

• Monitor the overall project scope from a client and account perspective and communicate scope changes when necessary   

• Provide final approval on all deliverables to ensure strategic objectives are met

• Develop and communicate status reports with management and the client, monitor project and team results against client expectations   

• Monitor and manage project-related risks and issues in partnership with the project manager; resolve and escalate risks and issues to the client when needed  

 This position is a perfect fit for you if: 

• Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

• You speak social media: X, Facebook, Instagram, LinkedIn, Snapchat, YouTube, Pinterest, you name it. You have in in-depth knowledge of today’s top social platforms 

What you should have:   

• BA/BS or equivalent required  

• 3-4 years of team leadership experience required  

• 3-4 years of client/customer management experience required  

• 2+ years in pharmaceutical sales/marketing preferred  

• 2+ years’ experience in strategic planning preferred

• Leadership experience in a corporate, marketing, or life sciences environment preferred  

• Project management experience preferred

Pay Range: $85,000-$100,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Development Scientist role is responsible for independently managing development projects and investigating improvements of technology that advance formulation development, process development, and manufacturing at Simtra. This role is also responsible for training scientists in formulation and process development for injectable products. The scientist reports directly to the Global Senior Scientist.

The responsibilities:

• Independently design and manage research studies that demonstrate the scientific capabilities at Simtra, solve challenging process development problems for potential clients, and that can be published in peer-reviewed journals and presented at scientific meetings.
• Collaborate with scientists in Bloomington and Halle to introduce potential new clients to Simtra, learn about their molecule / project, and propose possible directions for developing the product.
• Collaborate with the development scientists at both sites to overcome possible challenges in the development of a product.
• Investigate possible solutions to challenges that may be encountered during product development.
• Develop and utilize a digital twin during conjugation and purification of antibody drug conjugates and possibly other areas of development and manufacturing.
• Develop, implement, and optimize techniques and procedures in the field of formulation and lyophilization development or analytical development and validation. Develop a deeply differentiated technical skill set to contribute to department capabilities for product development.
• Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, supervisor, and technical advisor to junior members within the discipline.
• Implement new or improved techniques and procedures around specific tasks. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
• Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
• Examine the use of predictive modeling and data analysis for formulation and process development to improve platforms for client projects.
• Utilize operational excellence and statistical tools to improve experimental design, process efficiency, or quality/compliance.
• In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Maintain current knowledge of relevant quality and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Investigate routes of collaborating with start-ups or other companies to obtain funding for research and development initiatives.
• Interact and collaborate with Sales, Marketing, and Program Management groups to professionally introduce potential new clients to Simtra Development and Pre-Commercial Services as well as other teams and capabilities.
• Develop and conduct scientific training programs in formulation and process development for BDEs, PM, and clients in collaboration with business development.

Required Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Science or a scientific discipline with at least 15 years of relevant experience, or MS with at least 10 years, or a scientist with a PhD in Pharmaceutical science, Chemical Engineering, or a scientific discipline.
• Lab experience includes research in GMP environment, leadership of technical teams, and project management experience is desirable.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: TCU, Trackwise, etc.)
• Strong statistical skills and ability to use standard statistical software (examples include MiniTab, JMP) preferred.

Physical / Safety Requirements:

• Wear all PPE required by EHS (typically safety glasses, lab coat, gloves but may include a respirator).
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time.
• This position requires handling of laboratory chemicals
• Must be able to qualify for 20/25 corrected vision.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Principal Technical Transfer Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.

What you'll be doing:

• Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
  • Serve as the lead technical expert among a cross functional team
  • Lead the cross functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
  • Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
• Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of fill volume dosing qualifications (FVOQ)
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs]
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• SOP owner & process SME
• Perform filter troubleshooting
• Develops and presents in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services and helps with training and on-boarding
   

What you'll bring:

• BS degree required (preferably in a science or engineering related field
• 6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
• Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Experience in aseptic processing, sterile filtration, and process validation
• MS Office Suite advanced proficiency
• Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Physical / Safety Requirements:

• Require overtime work on occasion, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Project Manager, New Business acts as the primary leader for new business opportunities and client transfer activities.  This role leads projects through process development, validation, and commercialization activities by ensuring that all milestone requirements are delivered per agreed upon project specifications while balancing cost, resource and time commitments. They set appropriate customer and client team member expectations through the use of Project Management tools and guidelines while ensuring effective communications are achieved with all team members. The Project Manager ensures achievement of project objectives for assigned customers by mitigating risk and solving problems. 

This position reports to the Senior Manager, New Business in Bloomington, Indiana.

The responsibilities:

• Primary client facing role covering all aspects of product life-cycle, including proposal, contract, technical transfer and validation through commercialization. Supporting marketing and sales campaigns in order to understand client and market needs
• Performing technical evaluations of incoming new project opportunity requests, facilitating the Potential Product Evaluation and PAC meetings, initiating pricing discussions with finance, business development, sales and marketing and writing the final customized business proposal committing to scope, timeline, and cost.
• Participating in contract negotiations as decision maker for technical and site-specific business topics, as well as contract enforcement following agreement execution.
• Actively supporting client‘s filing and customer relationship management and business development initiatives to ensure client satisfaction.
• Ensuring smooth transfer to commercial team upon successful completion of project tech transfer and validation.
• Ownership of the Client Forecasting and Demand/Supply Obligations (Sales & Operations Planning) and ownership of client program Quarterly Business Review Meetings.
• Ensures roles and responsibilities are clear across internal and external organizations to achieve desired results.
• Leads internal and external project team meetings and ensures clear actions are documented and committed enabling timeline achievement.
• Ensures collaboration and respect are maintained in all experiences while constructively providing appropriate guidance and feedback.
• Primary contact for ongoing client projects and uses best practices in communication processes. Minimizes extraneous information and reduces non-essential communications. Manages information appropriately with all parties while sharing feedback and insight to drive improvements.
• Establishes expectations with all stakeholders and customers through clearly documented processes (Project Tracker, Scope Document, Timeline, and SharePoint). Ensures understanding through direct and active communication channels.
• Determine appropriate service recovery response and deliver message and appropriate action to customer while coordinating with internal partners. Effectively manages trade-offs between customer service, profitability and capabilities.
• Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies internally and/or with clients to ensure optimal results. Manages project interdependencies by use of project management tools that support monitor/control and effective risk management.
• Coordinates agreed upon scope change control when a change is proposed, ensuring financial obligations are assessed/collected from customer due to changes or additions to project scope.
• Utilizes Action Item List, timelines, project scorecards, project metrics, and deliverable tracking to drive project performance and ensure facility personnel understand progress and critical attention areas.
• Identifies opportunities for improvement and ensures internal partners take ownership and drive results.\Achieves billable project activities per business guidelines and approved project plans. Works with customer and sales to ensure additional work activities are billed and that the project meets profit guidelines.
• Contributes technical and product knowledge throughout the project lifecycle and understands balance and timing of involving appropriate technical resources throughout the project lifecycle through other experts when needed.
  
  

Required qualifications:

• Bachelor’s degree required, preferably in a business or scientific discipline
• Minimum of three years of pharmaceutical product development or manufacturing experience preferred and three years of project management experience preferred, preferably in a service business.
• Must be well versed in Project Management tools and must possess knowledge of related disciplines
• PMP certification desired
• Computer proficiency in Microsoft Word, Excel, PowerPoint, and Outlook and the ability to use enterprise software (examples include: JDE, Veeva, Trackwise, etc.)
  
  

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Ability to qualify for Grade C gowning required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Technical Transfer Associate (MSAT) is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
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EEO is the law - Poster Supplement 
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Job Summary

The Key Account Manager (KAM) for the Dry Eye Business Unit is responsible for launching and growing market share with a strong focus on driving demand through the payer channel in a defined geographic area, reporting to the Area Sales Manager (ASM). The Dry Eye product portfolio is Vevye. This position requires a highly motivated self-starter who offers solutions to challenges, has a positive presence with internal and external customers, is well organized, and can multitask in a continuously changing and dynamic ophthalmic market environment. Assigned monthly/quarterly/annual sales revenue and product objectives, which will be achieved through consultation and value-based communications with ophthalmologists, optometrists, and staff on the indication, use, characteristics, and advantages of Harrow ophthalmic branded formulations. Prospective candidates should have pharmaceutical or medical device sales experience and a proven track record of success selling to physicians, private clinics, hospitals, and support staff. This position requires about 70% travel.

Essential Duties & Responsibilities

• Meet or exceed quarterly sales revenue and product goals
• Takes 100% ownership and accountability to reach the goals set by the company
• Focus is on the development of new customers while converting the existing customer base
• Entrepreneurial mindset to analyze, develop, and grow the territory business

• Drive demand through organic pull-through and deploy any and all reimbursement solutions
• Call on ophthalmic healthcare professionals in defined markets
• Develop critical physician and staff relationships within the assigned geography
• Utilizes internal resources when developing quarterly action plans and partnering with accounts
• All sales activity is adequately recorded in CRM in a timely manner
• Competent in PowerPoint, Excel, Word & Outlook
• Maintain an in-depth and professional level understanding of our ophthalmic product portfolio and the competition
• Articulate the clinical benefits of the products/formulations and our solutions that complement them in a compliant manner
• Act with a sense of urgency at all levels of customer care and follow up
• Collaborate with internal departments and peers
• Ability to travel throughout the assigned geography on a routine basis
• Expected travel in the field will be about 75-80%, which may include overnight stays
• Understand the Pharmaceutical Industry’s Code of Practice
• Comply with all state and federal-specific legislation and regulatory requirements
• Manage expenses in a thoughtful, responsible, and ethical manner
• Resourceful thinker that may not have a complete roadmap to success but finds the resources available to win and prosper
• Acts as the liaison for customers with continual follow-up
• Submits all required reports, including monthly expense reports, on time

Knowledge, Skills & Abilities

• Bachelor’s degree in a related field
• Has 1-4 years of pharmaceutical or medical device sales experience (Ophthalmic experience is beneficial)
• Ability to build, develop, and foster longstanding relationships with customers
• Ability to quickly absorb product and practice information and offer solutions that resonate
• Experience with the execution of strategic and targeted business plans around priorities and goals
• Proficient with MS Office products, including Word, Excel, and PowerPoint
• Clinical understanding in the specialty of ophthalmology is preferred
• Knowledge of payer landscape, Commercial, Medicare Part D, and dual eligibility
• Knowledge of how physicians make decisions regarding patient care for various therapies
• Excellent presentation and interpersonal skills
• Solid independent judgment and initiative required
• Superior communication and written skills are a must
• Ability to multitask, adjusting priorities as needed
• Good problem-solving and analytical skills
• Ability to become proficient with the CRM System
• 70% weekly travel in a defined territory with overnights required

If you are unable to upload your resume in this system, please email Talentgroup@harrowinc.com 

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for the assigned geography and establish relationships with customers to drive demand for Sunosi (solriamfetol) in approved patients. SUNOSI is indicated to improve wakefulness in adults with excessive daytime sleepiness due to obstructive sleep apnea or narcolepsy. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels.

The Field SAM will be responsible for product performance at a territory level, be expected to be a disease category expert and a product champion, provide account management support, and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace.

Job Responsibilities and Duties include, but are not limited to, the following:

• Proficiency in both virtual and live customer engagements.
• Develop a comprehensive and effective territory business plan aimed at achieving and exceeding annual goals established by commercial leadership.
• Promote Sunosi within approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines.
• Develop strong customer relationships by better understanding the customer’s needs.
• Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials).
• Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers’ confidence to prescribe Axsome medications for appropriate patients.
• Communicate territory activity in an accurate and timely manner as directed by management.
• Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results.
• Successfully complete all training classes.
• Complete administrative duties in an accurate and timely fashion.
• Manage efforts within assigned promotional budget.
• Must be able to effectively collaborate across all corporate functions.
• Attend medical congresses and society meetings as needed.
• Ensure timely access for patients through patient services and savings programs.

Qualifications / Requirements 

• Bachelor’s degree from an accredited college or university.
• Minimum of 5 years of field customer experience and/or account management.
• Demonstrated experience delivering outstanding results.
• Minimum of 3 years Healthcare Professional experience with relevant CNS/Psychiatry experience will also meet the qualifications for this role.
• Previous pharmaceutical, biotech, or medical marketing/sales experience with at least five years in specialty sales preferred.
• CNS/Psychiatry experience preferred, but not required.
• Launch experience strongly preferred.
• Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals.
• Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment.
• Comfortability with uncertainty and high expectations.
• Patient support services experience a plus.
• Strong digital marketing aptitude.
• Strong interpersonal, presentation, and communication skills.
• Frequent driving, including extended periods of time behind the wheel.
• Prolonged sitting and standing as part of daily job functions.
• Ability to lift and carry up to 30lbs regularly.
• Overhead reaching required to close and secure liftgates or similar equipment.

Salary & Benefits

The anticipated salary range for this role is $110,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. 

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with customers, and ensure a successful sale of our products. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels. 

SAMs will be responsible for product performance at a territory level and expected to be a disease category expert and product champion. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. 

Job Responsibilities and Duties include, but are not limited to, the following:

• Proficient in both virtual and live customer engagements  
• Develop a comprehensive and effective territory business plan aimed at achieving and exceeding quarterly & annual goals established by commercial leadership 
• Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines 
• Develop strong customer relationships by better understanding the customer’s needs 
• Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials) 
• Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers’ confidence to prescribe Axsome medications for appropriate patients 
• Communicate territory activity in an accurate and timely manner as directed by management 
• Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results 
• Successfully complete all training classes in a timely manner 
• Complete administrative duties in an accurate and timely fashion 
• Manage efforts within assigned promotional budget 
• Effectively collaborate across all corporate functions 
• Attend medical congresses and society meetings as needed 
• Ensure timely access for patients through patient services and savings programs 
• Overnight travel as indicated by the needs of the business 
• Additional responsibilities as assigned 

Qualifications / Requirements 

• Bachelor’s degree from an accredited college or university 
• Minimum of 5 years of field customer experience and/or account management. Minimum of 3 years Healthcare Professional experience with relevant CNS experience will also meet the qualifications for this role 
• 5 years of consistent top performance in the pharmaceutical, biotech or medical sales space 
• Migraine/CNS experience strongly preferred 
• Demonstrated experience delivering outstanding results  
• Launch experience strongly preferred 
• Must live in the territory's geography 
• Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals 
• Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment 
• Comfortability with uncertainty and high expectations 
• Patient support services experience a plus 
• Strong digital marketing aptitude 
• Strong interpersonal, presentation, and communication skills 
• Frequent driving, including extended periods of time behind the wheel 
• Prolonged sitting and standing as part of daily job functions 
• Ability to lift and carry up to 30lbs regularly 
• Overhead reaching required to close and secure liftgates or similar equipment 

Salary & Benefits

The anticipated salary range for this role is $100,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

*** this territory will cover: Bloomington, Ft. Wayne, Hammond, Indianapolis, Peoria, South Bend, Springfield

Summary of Job:

The Regional Business Manager is a critical role in establishing KKI as a leader in Rare Diseases by demonstrating our commitment to supporting the efforts of Rare Disease healthcare providers in improving patient health outcomes and becoming a trusted resource in demonstrating value along the patient journey. 

The Regional Business Manager will understand education referral networks to identify appropriate patients and ensure maintenance on Crysvita by supporting appropriate multidisciplinary support of the patients via their care network.  

They will also work closely with the cross-functional teams at KKI.  

The Regional Business Manager serves as the lead point of contact for activities within the assigned hospital networks, academic Institutions, and surrounding practices and works closely with Market Access, Sales, Marketing, and Medical Affairs. 

Essential Functions:

• Maintain a high degree of clinical knowledge to engage effectively with Endocrinologists, Geneticists, and Rheumatologists in the areas of X-Linked Hypophosphatemia (XLH) and Tumor Induced Osteomalacia (TIO). 
• Focus efforts on achieving the greatest positive patient impact. 
• Manage patient identification by understanding the patient journey to aid in the diagnosis and thus enable access to therapy. 
• Clearly understand and implement the marketing plan, accurately articulate the value proposition, and utilize on-label and approved marketing materials only to attain sales/patient objectives for assigned products on a monthly, quarterly, and yearly basis. 
• Communicate all disease, product, and formulary information in a manner that is truthful and non-misleading, consistent with Kyowa Kirin's compliance policies and all applicable laws and regulations. 
• Individual must manage their territory using discretion and judgment when executing the brand strategy to maximize performance within the assigned customer population.  This may include physicians within specialty medical practices and their staff, specialists within local hospitals and clinics, and any other appropriate HCPs within their geographic area. 
• The Rare Disease Sales Specialist must be able to analyze local and regional business/managed markets trends to build both long and short terms goals that lead to a successful business plan. 
• Work compliantly in a matrix environment encompassing Patient Services, Specialty Infusion Pharmacies, and Managed Markets, which includes treating confidential patient information in accordance with Kyowa Kirin practices and policies. 
• Create productive business partnerships with internal customers to create compliant plans for selling approaches that align with the company and territory business plans. 
• Seek clarification from management and/or Compliance & Legal when uncertain whether a proposed activity could violate the law or compliance policies. 
• Utilize a consultative selling approach. This will be a highly technical, solution-oriented selling model enabling the representative to meet the needs of healthcare professionals who treat X-linked hypophosphatemia (XLH) and Tumor Induced Osteomalacia (TIO).  
• Manage a territory marketing and promotional speaker program budget in a manner that is consistent with all Kyowa Kirin compliance policies. 
• Share best practices and actively participate in Regional/National meetings. 
• Utilize CRM system to document account profiles, pre, and post-call activities. 

Compliant  

• Refers requests for off-label information to KKI’s medical department through the MIR process. 
• Strictly adhere to relevant regulatory and compliance guidelines and company policies. 

Job Requirements:

Education 

• Bachelor’s degree in Science or Business, MBA, Pharmacy/Medical Degree. 

Experience 

• Minimum of 5 years of specialty pharmaceutical sales experience. 
• Experience in making profound differences to patients by enabling access to the best treatments available. 
• Ability to discuss therapeutic strategies to inform and influence decision-makers. 
• Ability to successfully develop and apply clinical and business expertise, and effective selling skills. 
• Strong verbal, influencing, presentation, and written communication skills. 
• Reside within proximity to assigned geography. 
• Ability to adapt to changing business needs, conditions, and work responsibilities. 
• Displays an ongoing commitment to learning and self-improvement. 

Preferred: 

• Execution of marketing strategies at the local level. 
• Demonstrated business and strategic planning skills to identify unique selling opportunities and adaptability to changing market conditions. 
• Demonstrated understanding of managed care landscape and how it influences/impacts business. 
• Strong collaboration skills and success working in teams 
• Experience selling a product that requires extensive coordination with patient services. 
• Working knowledge of Rare Disease. 
• Demonstrated ability to analyze complex technical data and to develop strategic and actionable business plans. 

Travel Requirements: 

• Must have a valid driver’s license issued in the US with a clean driving record. This position will involve overnight domestic travel depending on the territory. 

Technical Skills 

• Proficient in MS Office Suite. 

Non-Technical Skills 

• Highly motivated and great attention to detail. Strong endurance to work under tight timelines and complex/changing situations.  Excellent written and oral communication skills. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility.   Cultural sensitivity and ability to develop consensus within a multinational organization. 

The anticipated salary for this position will be $180,500 to $202,400. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at  212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-PE1

#LI-Field

About the Job

This is a high-impact leadership role responsible for end-to-end supply chain and logistics operations supporting our manufacturing site and patient-facing fulfillment. As the Director of Supply Chain and Logistics, you will lead material planning, procurement, inventory management, cold chain logistics, and order fulfillment to ensure reliable, compliant, and efficient product delivery.

You will partner closely with Manufacturing, Quality, Engineering, MSAT, Sales, and Commercial teams to ensure seamless integration between supply and demand, positioning Supply Chain and Logistics teams as both an operational backbone and a strategic enabler of growth. As a key member of the Site Operations Team and leader of our Downstream Core Team, you will drive disciplined execution, visibility, and continuous improvement across the organization.

This role is ideal for a leader who thrives in complex, regulated environments, builds scalable systems, and is energized by ensuring life-saving products reach patients reliably and on time. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Supply Chain, Operations, Engineering, Business, or related field
• 10+ years of experience in supply chain, logistics, or operations in a regulated manufacturing environment (pharma, biotech, medtech preferred)
• 5+ years of people management experience leading supply chain or logistics teams
• Strong understanding of GMP/GTP requirements as they relate to materials, storage, and distribution
• Experience with inventory planning, procurement, and supplier management including ERP/MRP systems and inventory planning tools
• Proven track record of improving service levels, reducing shortages, and optimizing inventory
• Strong analytical, problem-solving, and communication skills

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing environments
• Experience with cold chain, time-sensitive distribution, and external logistics provider management
• Familiarity with S&OP/S&OE processes and cross-functional demand–supply alignment
• Experience driving supply chain optimization through automation, digital tools, or advanced analytics
• Lean or Six Sigma certification with demonstrated application in supply chain environments
• Experience supporting regulatory inspections (FDA, AATB, or equivalent)

Key Responsibilities

• Lead, mentor, and develop a high-performing supply chain and logistics teams across procurement, planning, inventory, and fulfillment
• Own end-to-end material flow from supplier through manufacturing to patient delivery
• Ensure reliable supply of materials and on-time fulfillment of finished goods to meet patient demand
• Establish and maintain inventory strategies that balance availability, risk, and working capital
• Oversee cold chain logistics, shipping, and distribution, ensuring product integrity and compliance
• Manage supplier relationships, including performance, risk, and continuity of supply
• Drive S&OE processes to align demand, supply, and execution across the site
• Identify and mitigate supply chain risks, including shortages, delays, and capacity constraints
• Partner with Manufacturing, QA, and Engineering to support production and capacity scaling
• Lead continuous improvement initiatives to increase service level, reduce cost, and improve efficiency
• Ensure compliance with GMP/GTP, internal procedures, and regulatory expectations
• Support audits and represent Supply Chain during regulatory inspections
• Develop long-term supply chain strategy aligned with commercial growth and new product launches
• Lead the site’s cross-functional Downstream Core Team, overseeing Release and Distribution processes to ensure reliable, compliant product availability
• Travel (domestic and international) when required (<10%) to support supply chain and logistics planning or projects

In your first six months some projects you’ll work on include:

• Assess current inventory levels, service levels, and supply chain risks across all products
• Strengthen supplier management and sourcing strategies for critical materials
• Optimize cold chain logistics performance, including carrier reliability and cost
• Develop a 12-24 month supply chain roadmap aligned with growth and product launches

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

Your Role:

As a key member of the sales/commercial team, the Territory Business Manager (TBM) will lead sales at the territory level and serve as the primary liaison between customers and SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany. The TBM will deliver on revenue goals by executing the brand objectives through communication of approved clinical information, rigorous account planning and commercial team collaboration. The TBM will be responsible for appropriately promoting our rare disease product(s) along with implementing programs and initiatives in accordance with the company and industry guidelines.

Location Classification – Field-Based: ​

Officially classified as working as a member of field organization, with the expectation of this role to travel and engage and with external partners, collaborators, and other third parties regularly on behalf of SpringWorks Therapeutics. #LI-Remote

Essential Duties and Responsibilities:

• Maintain an expert operating knowledge of all company policies and guidelines including but not limited to those addressing interactions with Healthcare Professionals, compliance and business conduct.
• Ensure compliance with all Company, industry and government laws or regulations including guidelines pertaining to ethical business practices.
• Accountable for overall territory revenue and customer support.
• Achieve short and long-term sales objectives by identifying customer needs and providing solutions to create a professional relationship between the customer and SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany. in both the live and virtual setting, as well as, within the community/academic setting respectfully.
• Build relationships with key HCP’s, physician practices, and hospitals/clinics, practice managers across various treatment and academic settings, including major cancer centers.
• Be a territory expert having deep market, customer, product, and competitive insights. Understand the changing healthcare landscape and strategically adapt to succeed in a constantly evolving environment.
• Successfully complete ongoing training and development to include product knowledge, selling skills, goal setting, planning and analysis, use of marketing tools and clinical information and sales competencies.
• Strategically identify and enact ways to appropriately put patients and customers first, demonstrating behaviors and prioritizing those tasks which will enable delivery of medicines to patients with greater speed and increase the ability to help patients’ lives.
• Demonstrate strong critical analytic and planning skills in reviewing data, understanding trends, preparing, communicating applicable plans and embracing the digital platforms/omnichannel strategies.
• Fully participate in field coaching sessions, including receiving guidance, positive reinforcement, and corrective action where needed with a focus on the execution of accounts plans and competency development to ensure revenue targets are met.
• Work collaboratively and manage ongoing communication and tactical coordination with field and HQ colleagues.
• Work to support local/area KOL’s.
• Perform other duties and responsibilities as assigned.

Education & Qualifications: 

• Bachelor’s degree required (Advanced degree preferred)
• 7+ years of pharmaceutical and/or biotech experience required
• 5+ years proven Rare Disease sales experience in the pharmaceutical/ healthcare industry with demonstration of successful results
• Oncology experience
• Experience selling in a competitive market
• Experience with virtual selling and track record of embracing technology
• In-depth understanding of the Oncology landscape and market dynamics is highly desirable
• Strong expertise in reimbursement and managed care knowledge
• Possesses high integrity and exceptional work ethic. Fosters mutual trust and respect
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual performance
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.

Physical Requirements of Position:

• A valid and active driver’s license
• Position may require domestic travel up to 50% of time
• Candidate must live within the identified territory #LI-Remote

Compensation & Benefits:

The expected salary range for this position is $185,000.00 to $210,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary incentive compensation is available based on individual performance tied to MBO's and Sales Incentive Plan.

Who is Authenticx?

Authenticx is an AI powered conversation intelligence platform purpose-built for healthcare that surfaces the barriers, operational hurdles, and customer frustrations behind every care interaction. We are on a mission to help humans understand humans. Our software platform is the new standard for humanizing customer interaction data at scale. We do this by channeling our passion and talent into helping health care leaders listen to their conversational data in a way that delivers value to the enterprise.

What do we offer our team members?

• A culture based on our core values of Authenticity, Courage and Having Fun
• A collaborative environment that supports your personal and professional development
• Remote/virtual working flexibility
• Free health insurance options
• Comprehensive benefits - medical, vision, dental, life, and disability insurance
• HSA and FSA plans
• 401(K)
• Unlimited vacation time
• Generous paid holidays, sick leave, and parental leave
• Perks at Work membership for discounts on shopping, travel and much more