POSITION OVERVIEW:

As Disc Medicine transitions from a clinical-stage organization to a commercial-stage one, the company is introducing a new role: Director of Clinical Quality Control. The successful candidate will play a crucial role in driving the company’s growth and achieving strategic objectives.

The Director of Quality Control will manage stability studies for various small-molecule and biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include protocol design; coordination and execution of various stability studies at CDMOs; statistical analysis; and expiration dating.  Additionally, this role will oversee the end-to-end supply of reference standards for quality control testing, including sourcing/production, qualification, inventory and distribution, as well as lifecycle monitoring. Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets.

This position reports to the Head of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have at least 10 years of experience in quality control management in the pharmaceutical or biotech industry.

RESPONSIBILITIES:

This role will have extensive technical expertise and be responsible for stability and reference standard management for Disc Medicine’s clinical development programs. The technical responsibilities include:

• Evaluate, select, and manage CDMOs for QC stability testing.
• Direct stability studies per ICH guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve SOPs, stability protocols, and reports in accordance with current GMP, ICH, and global regulatory guidelines.
• Create, implement, and manage stability databases, forecast stability testing, and report on metrics, perform data trending and statistical analysis to support expiry dating. 
• Manage Quality System records for QC Stability: create, assess, review Deviations, Change Controls, CAPAs, and other applicable stability-related investigations and events
• Oversee the sourcing, characterization, qualification, retesting, and inventory management of primary and working reference standards.
• Author and review the stability and reference standard sessions of the global health authority dossier for clinical trials and commercial licensure.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

 REQUIREMENTS:

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 10 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Knowledge of product stability, setting of specifications, product shelf-life management, and experience with QC OOS investigations.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with Veeva, LIMS and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
• Experience with method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced small molecules and biologics therapeutics.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
• Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel up to 25%.
• Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

Your Impact

We are looking for a forward thinking and highly motivated team player to join our Accounting Strategy and Financial Reporting team. You will lead accounting research and operational analysis with a primary focus on M&A, strategic equity and debt investments, new accounting and reporting standards, and other special projects. You will also have an opportunity to support the SEC reporting and earnings release process, including overseeing aspects of financial statement disclosures and involvement with reporting non-GAAP financial measures.

In this role, you will collaborate closely with our Strategy and Corporate Development team and, where applicable, strategically advise them on the accounting implications of unique transactions. Additionally, you will be involved in the development of clear, actionable accounting policies and informative trainings. You will also have an opportunity to present your research results and assessment findings and recommendations to senior leadership and key cross-functional stakeholders.

What You’ll Do

Work Location: This role is eligible to be based out of any of Axon's US hub offices (Atlanta/Peachtree Corners, Boston/Back Bay, NYC/Manhattan, Phoenix/Scottsdale, San Francisco/Presidio, Seattle/Downtown) and follows a hybrid schedule. We rely on in-person collaboration and ask that team members work onsite Tuesdays through Fridays, with the flexibility to work remotely on Mondays, unless there is an approved workplace accommodation. We believe that connection fuels innovation, and our in-office culture is designed to foster meaningful teamwork, mentorship, and shared success.

Reports to: Vice President of Financial Reporting and Strategic Investments

• Participate on cross-functional teams as a representative of the Finance organization in evaluating the accounting for potential M&A and investment areas and ad-hoc specific opportunities being considered by the Company.
• Create and review technical memoranda, accounting policies, training materials, and other documentation supported and corroborated by research, analysis and concise conclusions.
• Articulate issues and recommendations in a crisp and concise manner to both financial and non-financial stakeholders to enable better decision-making.
• Establish, maintain, and provide expertise on current and upcoming U.S. GAAP, including topics specific to M&A, private and public equity, debt instruments, consolidation, VIE and equity-method accounting, and the related presentation and disclosure requirements.
• Lead and/or contribute to relevant projects on behalf of the accounting team, such as acquisitions or other strategic investments and new accounting pronouncements.
• Work closely with other stakeholders to assist in the integration of acquisitions and strategic partnerships.
• Assist in the identification and resolution of key US GAAP and SEC reporting issues and formulation of findings into memos and disclosures.
• Assist in the preparation and tie out of Forms 8-K, 10-Q, and 10-K, external presentations and reports and peer disclosure benchmarking.
• Periodically assist in the review and advise key leaders on significant contract implications.
• Proactively monitor and operate a robust internal control environment in compliance with Sarbanes-Oxley or similar requirements.
• Collaborate with other departments to support company initiatives.

What You Bring

• Bachelor’s Degree in Accounting, Finance, Business, or similar field required.
• At least eight years of experience with a top-tier accounting (Big 4 strongly preferred) or strategy firm. National Office and/or transactional advisory experience preferred.
• CPA designation required.
• Strong technical knowledge of US GAAP (familiarity with ASC sections 805, 810, 815, 820, 606, 321, and 323 preferred) and SEC reporting requirements.
• Ability to research technical accounting matters and prepare well written memorandums and presentations articulating these matters to well versed accountants and non-finance stakeholders both internal and external to the organization.
• Sarbanes-Oxley Act (SOX) experience and the ability to implement business processes required to ensure compliance with its tenets.
• Ability to leverage Artificial Intelligence tools (i.e. ChatGPT) to enhance productivity of yourself and the organization.
• Superb attention to detail, strong planning and organization skills, and the ability to multi-task, prioritize and deliver in a fast-paced, dynamic environment.
• Professional and driven “can-do” attitude.

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

Benefits listed herein may vary depending on the nature of your employment and the location where you work.

The Role 

This role is remote, with 50% travel to the states we have cultivation/production facilities, primarily travel will be in mid-west and east coast but could be in any of the 14 states we operate. 

GTI just keeps growing and growing! We’re seeking a logistical genius and construction management guru to oversee CPG construction projects.  As a Construction Project Manager for GTI CPG, you will be responsible for serving as the liaison between GTI HQ and our Cultivation/Processing Facility build-outs in the field ensuring scope of work is executed, quality of brand is maintained, timelines are beat, and budgets are always in the green! You should have off the charts communication skills to work with sub-contractors/vendors and your teammates alike. As a proven Construction PM, you have managed 20+ projects at a time working across a national landscape. 

Responsibilities 

Manufacturing Facility Construction (Primary Focus)

• Lead full lifecycle construction of manufacturing facilities from site feasibility through commissioning and turnover
• Oversee build-outs for:
• Commercial production kitchens
• Infusion and formulation labs
• Packaging and labeling lines
• Automated filling and bottling systems
• Vaults and finished goods storage
• Cold storage and environmental-controlled rooms
• Coordinate sanitary design standards and cGMP-aligned construction
• Ensure compliance with:
• Local health department regulations
• OSHA requirements
• State cannabis manufacturing regulations
• Food-grade and pharmaceutical-grade standards where applicable
• Manage integration of:
• Process utilities (compressed air, steam, chilled water)
• High-capacity electrical infrastructure
• HVAC systems for temperature and humidity control
• Cleanable wall/ceiling systems and floor coatings
• Oversee equipment procurement, vendor coordination, installation, and startup sequencing
• Lead commissioning and operational readiness efforts with site manufacturing teams

Extraction Facilities (Secondary Focus)

• Support construction of:
  • Hydrocarbon, ethanol, CO₂, and solventless extraction rooms
  •  Post-processing and refinement labs
  • Solvent storage and recovery systems
• · Coordinate C1D1 / C1D2 rated spaces and hazardous electrical systems
• · Ensure compliance with NFPA, fire code, and AHJ requirements
• · Manage specialized HVAC and gas detection systems

Cultivation Facilities (Secondary Focus)

• Support build-outs of:
  • Flower, veg, and propagation rooms
  • Drying and curing spaces
  • Irrigation and fertigation systems
  • Environmental control (HVACD) systems
• · Coordinate high-load mechanical systems and infrastructure upgrades

Core Project Management Responsibilities

• Direct all phases of construction management:
  • Feasibility and due diligence
  • Budget development and cost control
  • Scheduling and resource planning
  • Design coordination
  • Field execution
  • Commissioning and close-out
• Develop resource-loaded critical path schedules
• Prepare and manage capital budgets and cashflow projections
• Act as single point of contact between HQ, site leadership, engineering, vendors, contractors, landlords, and governing authorities
• Track project performance across cost, schedule, scope, and quality metrics
• Identify and mitigate operational and regulatory risk
• Maintain strict adherence to corporate quality, safety, and brand standards

Qualifications 

• Bachelor’s degree in engineering, Construction Management, Architecture, or related field, preferred
• 5+ years of project management experience, preferred

• Preferred experience with: 

• Controlled Environmental Agriculture (CEA) 

• Greenhouse or indoor grow facilities 

• High-capacity HVAC and mechanical systems 

• Industrial electrical distribution systems 

• Experience managing multi-site, multi-state expansion programs 

• Strong understanding of environmental controls and agricultural infrastructure preferred 

Technical Skills 

• Proficient in construction management software such as: 

• Primavera P6 

• Procore 

• Timberline 

• PlanGrid (or similar) 

• Advanced Microsoft Project and Excel (budget tracking, forecasting, modeling) 

• Ability to interpret mechanical, electrical, irrigation, and environmental control drawings 

• Experience coordinating large mechanical subcontractors and specialty vendors 

Professional Attributes 

• Highly analytical and systems-oriented 

• Strong critical thinking and problem-solving capabilities 

• Comfortable managing 15–20+ concurrent projects nationally 

• Effective communicator across operations, engineering, compliance, and executive leadership 

• Operates with professionalism and integrity 

• Thrives in fast-paced, high-growth environments 

Additional Requirements 

• Must pass all required background checks 

• Must remain compliant with all applicable state and company regulations 

• Flexible schedule required, including occasional evenings/weekends during critical project phases 
• Willingness to travel nationally as required 

What we're looking for:

What we're looking for:

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

About the Role:

Stylus Medicine is seeking an intellectually curious and collaborative Senior Scientist, who will lead the development of upstream microbial fermentation processes as part of our CMC Tech Ops team. This role will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to pilot. Working closely with the Research, Preclinical, and Formulation teams, this is a special opportunity to advance the development of transformative in vivo genetic medicines.

Key Responsibilities & Accountabilities:

• Develop scalable production processes for nucleic acids and recombinant proteins
• Leverage expertise in fermentation and mammalian cell culture to design, optimize, scale-up and characterize production processes
• Independently utilize multivariate design of experiment (DoE) approaches to improve productivity and optimize parameters for product quality
• Drive fermentation platform development and new technology implementation to improve process performance, generation of predictive process models, and enhance process control and robustness
• Design and implement in-process analytics to improve productivity while reducing process and product derived impurities
• Maintain and troubleshoot equipment to ensure consistency and continuity of operations
• Document, analyze and present experimental results internally and externally
• Partner with CDMOs and provide technology transfer support to facilitate scale up
• Interface with cross-functional teams to ensure programs are on track and stakeholders’ needs are met
• Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

Qualifications & Skills:

• PhD in Chemical/Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline with >4 years of experience, or BS/MS with >8 years of experience in biopharmaceutical or biotechnology development, including experience in developing scalable fermentation processes for producing plasmid DNA and/or recombinant products
• In-depth experience and knowledge in fermentation process development, optimization, and process scale-up / scale-down model development
• Familiarity with strain engineering and biocatalysis
• Familiarity with performing operations in a cleanroom environment, applying controls to ensure aseptic processing
• Demonstrated ability to coach and mentor junior researchers
• Independently motivated and good problem-solving ability
• Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must
• Demonstrated ability to work collaboratively across teams to meet project deliverables and timelines
• Strong communication, decision-making and organizational skills
• Proficiency with statistical analysis software (e.g., JMP) is highly desired
• Prior experience partnering with external CDMOs and conducting tech transfers preferred

Pay Range: $155,000 - $170,000

POSITION OVERVIEW:

Disc’s Corporate Strategy group partners across the organization to advance our strategic agenda and support initiatives that will drive the company forward. The Senior Manager, Strategy and Corporate Development will be responsible for supporting high-impact strategic and growth initiatives, including corporate planning, transactions, new product planning, commercial assessment, market and competitive intelligence, assisting with commercial preparations, and corporate communications.

RESPONSIBILITIES:

• Corporate Strategy (~35%)
  • Support strategic initiatives that will address mission-critical questions and position Disc for future success
  • Support commercial preparation activities, including market shaping, launch planning, value proposition development, and positioning
  • Monitor, understand and prioritize external trends of relevance to the company, and help determine how Disc should prepare and/or respond
• Competitive Intelligence and Market Insights (~15%)
  • Critically evaluate available information about Disc’s diseases of interest and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
  • Support consulting and market research projects to gain deeper insight into markets of interest for Disc
• New Product Planning (~25%)
• Research, evaluate and recommend potential growth strategies through expansion into new therapeutic categories, markets, and related businesses
• Lead analyses of commercial opportunities (including epidemiology modeling and detailed revenue projections) related to corporate/business development initiatives
• Communications Support (~15%)
  • Support external communications, including drafting press releases and developing corporate presentations
  • Maintain and update corporate website
• Business Development (~10%)
  • Assist business development processes by providing expertise for in- or out-licensing, partnering and acquisition activities, as well as contributing to deal sourcing, due diligence, and negotiations
  • Support development and maintenance of Disc valuation model and supporting documents

 REQUIREMENTS:

• Bachelor’s degree required
• Minimum of 4 years of experience at a top-tier strategic consulting firm or investment bank, preferably with healthcare and pharma industry experience, or at a biotech or pharma company in a similar role
• Demonstrated ability to independently lead projects or project modules, including formulation of research plan, conducting primary or secondary market research, identifying and managing vendors, performing analysis, and distillation of findings into recommendations for management consideration
• Strong analytical skills with the ability to interpret complex data and market insights
• Proven ability to develop deep working knowledge of clinical programs and therapeutic landscapes
• Ability to create and deliver effective presentations to working teams and senior management
• Ability to create complex excel-based forecasts and valuation models
• Ability to thrive in a fast-paced, dynamic startup environment with a hands-on, proactive approach
• A hands-on approach with a willingness to handle both high-level strategy and day-to-day execution
• Strong communication skills, can comfortably lead meetings with mid/senior-level management

What You’ll Do:

This Senior Scientist will support ongoing activities for drug product formulation and manufacturing with external partners and CDMOs. This would include manufacturing process development and optimization, clinical supply manufacture, and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development through all stages of clinical development.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
• Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
• Review master batch records and executed batch records to ensure product quality
• Author change controls, review specifications, change notifications, and manage manufacturing deviations as necessary, working closely with Kailera’s quality group
• Present formulation development and manufacturing updates to internal and external stakeholders periodically
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD, and NDA)

Required Qualifications:

• 5+ years of experience in solid-oral dosage form development. Technical expertise in unit operations common to solid oral dosage form (e.g., milling, wet/dry granulation, compression, and film-coating)
• Extensive experience with management of day-to-day activities at CDMO’s
• Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
• Strong working knowledge of Microsoft suites and common scientific software
• Experience with design of experiment (JMP/Minitab)
• Experience using quality systems such as Veeva to author and approve documents
• Excellent verbal, written, and interpersonal skills
• Ability to travel up to 10-20% (domestic and international)

Preferred Qualifications:

• Experience in the GLP-1 space, late-stage development

Education:

• B.S. and 12+ years of experience, advanced degree with 10+ years, or a PhD with 5-8 years of experience
• Degree in Engineering, Pharmaceutical Sciences, Chemistry or closely related field

What You’ll Do:

The Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of commercial and clinical supply management and strategy, global regulatory requirements, and project management practices. The Director, Global Supply Chain partners with relevant internal functional groups to ensure uninterrupted supply of both Investigational Medicinal Product (IMP) for clinical studies as well as inventory of commercial drug products.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support commercial launch readiness, including vendor management, distribution planning, and leading the Supply and Operations Planning team
• Managing drug product supply and logistics activities including, but not limited to, demand forecasting and supply planning (clinical and commercial), IRT, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
• Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
• Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
• Providing day-to-day oversight of Packaging and Labeling/Distribution vendors, including relationship management
• Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
• Proactively identifying potential issues, notifying Management in a timely manner, and developing mitigating actions
• Coordinate the development of the commercial forecast
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts and develop supply plans
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
• Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
• Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
• Ensure temperature excursion processes are executed as required
• Guide the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
• Leverage inventory management capabilities of the IRT to appropriately manage clinical and commercial drug supply

Required Qualifications:

• Experience with global pharmaceutical development and manufacturing operations for development-stage and commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
• Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
• 8+ years of experience in clinical supply management
• Ability to cross-functionally communicate effectively with a high degree of emotional intelligence
• Deep understanding of IRT systems
• Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
• Strong computer skills including MS Office
• Hands-on, roll-up-your-sleeves, collaborative approach with a high sense of urgency and personal accountability to drive toward results
• Ability to think outside of the box and challenge the status quo
• Desire to work in a fast-paced, innovative environment
• Domestic or international travel is required (up to 20%)

Preferred Qualifications:

• Experience with pharmaceutical development and manufacturing operations for development-stage clinical products
• Experience with combination product device(s)

Education:

• Bachelor’s degree in pharmaceutical science, engineering, life sciences, or another relevant field. Advanced degree preferred

Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)        

Location: Hybrid – Waltham, MA required to be in-office 3 days/week. 

Position Overview: 

We are seeking an experienced and motivated MSAT (Manufacturing Science and Technology) leader to lead downstream late-stage and pivotal enabling optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for process development, troubleshooting production issues, data analysis, and ensuring compliance with regulatory standards to maintain product quality. The successful candidate will be involved in late-stage drug substance manufacturing and process validation activities in support of BLA filing. This role involves working in a fast-paced environment and drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.  

Key Responsibilities:

• Oversee the transfer of manufacturing processes from late-stage development to large-scale production at the CDMOs for multiple programs.
• Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to commercial manufacturing.
• Build strong relationships and partner cross functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• Partner with late-stage process characterization and MSAT teams and develop robust control strategy enabling successful PPQ DS campaigns
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Support regulatory filings by authoring high quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs).
• Perform MFG/MSAT risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements.
• 20-25% travel in support of manufacturing activities at CDMOs.

Qualifications:

• Master’s or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with at least 8 years of relevant experience developing, scaleup, and transfer of downstream processes for biologics.
• Significant experience managing manufacturing in an MSAT environment. Direct hands-on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process robustness, facility fit and overall commercial readiness.
• In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
• Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development.
• Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns, with emphasis on phase appropriate control strategy.
• Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Self-starter with a strategic mindset and ability to thrive in a fast-paced, collaborative environment.      

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $175,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

About Formlabs:

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Your Impact: 

Materials development presents one of the greatest opportunities to innovate in 3D printing, unlocking new applications in different industries such as engineering, consumer, manufacturing, automotive and healthcare. Our materials science team works closely with product management, hardware and software teams to develop new materials that push the boundaries of what can be done with 3D printing.

If you are a scientist or engineer with experience in polymer development who’s excited to break new ground in an industry that’s moving at lightning speed, we want you as a Materials Scientist - Photopolymer Development!

What You’ll Do:

• Design and optimize complex photopolymer formulations to push the boundaries of additive manufacturing.
• Lead the end-to-end transition of new materials from lab scale concept to commercial launch, supporting technology transfer and scale-up.
• Establish structure-process-property relationships through rigorous experimentation and analytical characterization to meet demanding product specifications.
• Learn about the 3D printing process and underlying hardware, and use that knowledge to inform formulation decisions and provide input to future hardware decisions.
• Collaborate cross-functionally with product management, hardware, and software teams to develop products that meet customer needs and work seamlessly on the Form 4 platform.

About You:

• BS, MS, or PhD in polymer science, chemical engineering, chemistry, materials science or a related field.
• Results-oriented and motivated by delivering products in a fast-paced R&D environment.
• Experience developing thermoset materials including epoxies, urethanes, or acrylates.
• Enjoys working hands-on in the lab conducting experiments and analyzing large data sets to drive decision making.
• Able to work autonomously and push projects forward with a high level of independence. 
• Track record of success including publication, IP generation, or product commercialization.
• Practices good documentation and can organize complex data, create SOPs, and write clear, detailed internal reports.

Bonus Skills:

• Familiarity with additive manufacturing technologies
• Programming and digital analysis (Python, JMP, MATLAB, Minitab etc)
• Experience with high performance polymers, composites, or elastomers

Our Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

About Formlabs:

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Your Impact: 

Materials development presents one of the greatest opportunities to innovate in 3D printing, unlocking new applications in different industries such as engineering, consumer, manufacturing, automotive and healthcare. Our materials science team works closely with product management, hardware and software teams to develop new materials that push the boundaries of what can be done with 3D printing.

If you are a scientist or engineer with experience in polymer development who’s excited to break new ground in an industry that’s moving at lightning speed, we want you as a Materials Scientist - Photopolymer Development!

What You’ll Do:

• Design and optimize complex photopolymer formulations to push the boundaries of additive manufacturing.
• Lead the end-to-end transition of new materials from lab scale concept to commercial launch, supporting technology transfer and scale-up.
• Establish structure-process-property relationships through rigorous experimentation and analytical characterization to meet demanding product specifications.
• Learn about the 3D printing process and underlying hardware, and use that knowledge to inform formulation decisions and provide input to future hardware decisions.
• Collaborate cross-functionally with product management, hardware, and software teams to develop products that meet customer needs and work seamlessly on the Form 4 platform.

About You:

• BS, MS, or PhD in polymer science, chemical engineering, chemistry, materials science or a related field.
• Results-oriented and motivated by delivering products in a fast-paced R&D environment.
• Experience developing thermoset materials including epoxies, urethanes, or acrylates.
• Enjoys working hands-on in the lab conducting experiments and analyzing large data sets to drive decision making.
• Able to work autonomously and push projects forward with a high level of independence. 
• Track record of success including publication, IP generation, or product commercialization.
• Practices good documentation and can organize complex data, create SOPs, and write clear, detailed internal reports.

Bonus Skills:

• Familiarity with additive manufacturing technologies
• Programming and digital analysis (Python, JMP, MATLAB, Minitab etc)
• Experience with high performance polymers, composites, or elastomers

Our Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Purpose/Summary:

This position is responsible for all aspects of Chemistry, Manufacturing, and Controls (CMC) drug product development from early stage to late-stage clinical development and commercialization, including development of efficient and scalable manufacturing processes, technology transfer, manufacturing of clinical supplies, and management of supply chain for clinical supplies. She/he is also responsible for preparation and review of all CMC regulatory filings. 

At this stage, the primary activities are focused on supporting Phase 3 clinical trials, including manufacturing clinical supplies, managing resupply needs, and overseeing the clinical trial supply chain and drug/device combination product interface.

The Head of Drug Product Development leads activities of an internal multifunctional team and network of external Contract Development and Manufacturing Organization (CDMO) partners working on all aspects of CMC development.  Functional responsibilities as project leader include formulation and manufacturing process development, oversight of drug product development, technology transfer and scale-up, and oversight of packaging and labeling, clinical supply chain, and CMC project management for drug product and drug/device combination product interface related activities.  Must possess strong leadership experience including strong CMC expertise and good technical understanding of the inter-disciplinary nature of drug development demonstrated by previous experience with injectables and drug/device combination products. She/he will collaborate closely with cross-functional internal and primarily external (CDMOs) team members in CMC development, Regulatory, Quality, Clinical Operations and Development during all phases of product development Ph 1- Ph 3, technology transfer, validation, manufacturing and filing IND, IMPD, NDA, MAA registration.

Essential Functions:

• Lead internal and CDMO Drug Product teams and represent Drug Product Development in multidisciplinary project teams as a project leader, work collaboratively to ensure project progression, and communicate Tech Ops strategy and related challenges.
• Encourage innovative, cross-functional thinking, and engagement of outside expertise as appropriate to help further Tech Ops/Corporate goals
• Ensure robust planning and execution of product development efforts across Ironwood's portfolio of development candidates from IND, Ph1, Ph2, Ph3 to commercialization. Proactively identify and mitigate risks to advance products in a timely manner.
• Ensure effective communication with key partners internally (particularly program management, regulatory, clinical development, and quality) and with an external CDMO network.
• Set Drug Product team budget and have financial accountability for drug product development activities per the annual operating plan.
• Responsible for Drug Product CDMOs timelines and Drug Product functional planning by providing technical oversight to ensure that Ironwood’s development and clinical manufacturing needs are met.
• Provide oversight to the clinical trial supplies team managing the inventory/delivery of Investigational products.
• Apply formulation and manufacturing principles, theories, and techniques to product development, and ensure development of the best possible phase-appropriate formulations.
• Supervise Drug Product and Clinical trial Supply scientists internally and externally to deliver on chemical, formulation, and analytical drug product development goals.
• Enable risk-based and compliant development practices: Identify and evaluate risks and provide recommendations to close via internal or external collaborations. Ensure development activities are documented per Ironwood documentation policies and underlying data are traceable.
• Author and/or review technical reports and relevant CMC sections for regulatory submissions (INDs, IMPDs, NDAs, etc.). Accountable for content development of FDA and exUS regulatory filings in collaboration with Regulatory, Quality, Supply Chain and members of the Development teams.

Requirements:

• PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry, or related scientific field with at least 15 years of industrial experience with at least 10 years of senior leadership experience in leading CMC/formulation teams especially in the injectable space (more specifically vials, both liquid and lyophilized drug products).
• Experience with injectable drug products containing synthetic peptides.
• Experience with leading drug product teams for injectable products during Phase 3, process validation, launch readiness and transition to commercial production.
• Experience with early phase development (pre-clinical, and Phase 1) a plus.
• Demonstrated experience supporting drug–device combination product development, with specific expertise in fill‑finish processes (e.g., prefilled syringe, autoinjector, dual-chamber cartridge) and conducting drug product–device / container compatibility evaluations.
• Experience with clinical studies and supply chain management oversight a plus.
• Comprehensive understanding of all aspects of CMC including process and formulation development, analytical science, regulatory, and quality.
• Strong group leadership, communication, and collaborative skills (both cross-department and with development partners). Experience working with global teams is strongly desired 
• Experience in managing development and manufacturing activities at global CDMOs
• Experience with synthetic peptide manufacturing processes, injectable drug product manufacturing, and finished goods primary packaging 
• Working knowledge of approaches for characterization of solution and solid-state properties of materials, and technologies for delivery of synthetic peptides
• Excellent data analysis skills and the ability to make recommendations that impact the scientific and business goals of the company. Ability to articulate complex issues and ideas with clarity to enable understanding and direction.
• Solid understanding of ICH, FDA, EMEA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of product development
• Strong understanding of drug–device combination product development, including primary container interactions, fill‑finish considerations, and drug product–device compatibility
• Experience with submissions and interactions with regulatory agencies regarding CMC issues during product development and primary container/packaging for drug-device combination products. Thorough knowledge of INDs, IMPDs, MAAs, NDAs, etc.
• The ability to work successfully in both a team/matrix environment as well as independently is required
• The ability to influence cross-functionally to enable development improvements and team performance.
• Good communication, project management, and interpersonal skills
• Effective and innovative problem-solving skills

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Ironwood currently anticipates that the initial base salary for this position could range from between $246,000 to $286,650.  The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.

We are looking for a highly motivated and innovative candidate for the role of Associate Scientist II / Senior Associate Scientist of Nanoparticle Process Development. This individual will support in production and scale up of LNPs with nucleic acid payload. Reporting to the Principal Scientist of Nanoparticle Process Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with deep scientific knowledge.

Primary Responsibilities:

• Execute experiments related to LNP mixing and downstream purification/filtration to improve the process.
• Contribute to development of a robust formulation process with emphasis on scale-up, tech-transfer and stability.
• Contribute to thorough characterization of LNPs by existing methods and collaborating with internal stakeholders on developing new methods.
• Coordination with other team members to support the group's research activities in a fast-paced and collaborative environment.

Qualifications:

• B.S. with at least 2-5+ years of relevant experience or M.S. with at least 1-3+ year of relevant experience with an educational focus in Chemical Engineering, Bioengineering or similar preferred.
• Experience with LNPs required and nucleic acid payloads required.
• Experience with TFF required with emphasis on LNPs highly preferred for Associate Scientist II level, required for Senior Associate Scientist level.
• Experience with QbD principles, scale up efforts and JMP DOE is a plus.
• Experience with various mixing geometries as well large scale LNP production preferred for Associate Scientist II level, required for Senior Associate Scientist level.
• Strong collaboration and inter-personal skills.
• Ability to multi-task and prioritize to meet important deadlines.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $84,000 - $100,000 annually plus bonus and equity incentives