JOB SUMMARY

Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.

With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. 

This position is located in Lexington, MA and reports to the MFG Supervisor.

ESSENTIAL JOB FUNCTIONS

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.

Primary responsibilities include the following:

• Attend daily meetings including shift hand off and ensure relevant information is shared between shifts
• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state 
• Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
• Demonstrating general knowledge of aseptic techniques 
• Perform troubleshooting activities according to SOPs 
• Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed
• Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms   
• Perform page reviews in BPRs, SLRs, Logbooks, and Forms  
• Carry out work in a safe manner, notifying management of safety issues and risks 
• Maintain up-to-date training folder for applicable processes 
• Required to work holidays and overtime as needed to support the manufacturing process

This individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment 
• Perform standardization of equipment 
• Support product change over activities 
• Support equipment and process qualifications if needed 
• Escalate work requests to Senior or Lead Technicians for submission in work request management system 

Staff Technical Training and Development:

• Propose continuous improvement, process, and human performance document revisions
• Escalate and contributes to process improvement and manufacturing Continuous Improvement items
• Develop and maintain personal development plan
• Provide annual performance self-assessment

SPECIAL JOB REQUIREMENTS

• Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP
• Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization  
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures  
• Hands-on experience in writing and reviewing documentation  
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Good writing and oral communication skills  
• Applies experience and skills to complete assigned work within own area of expertise
• Works within standard operating procedures and/or scientific methods
• Comfortably able to lift up to 40lbs  
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 20 pounds
• Rarely lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

The QC Senior/Principal Scientist for Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department within our CDMO facility. The individual in this role will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance. Lead transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen’s services and commercial products in compliance with company policies and procedures and regulatory guidelines.

ESSENTIAL JOB FUNCTIONS 

• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
• Works independently and is responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production.
• SME for cell-based and analytical method protocols and reports related to QC Method transfer, qualification, feasibility and validation.
• Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification.
• Responsible for monitoring analytical method performance, including assessment of analytical method system suitability requirements.
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
• Coordinate with Critical Material Sr. Scientist to design and qualify critical materials required for cell based methods to support phase appropriate readiness
• Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting.
• Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, ddPCR / qPCR, ELISA, Potency Assay, plate-based assays, CE-SDS, SDS-PAGE and western blot) and/or viral vector manufacturing.
• Familiar with FDA and EMA guidance documents relevant to gene therapy.
• Working knowledge of quality systems requirements.
• Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
• Interface with clients and Genezen cross-functional teams to define technical requirements and provide routine project updates.
• Assure that laboratory procedures are current and facilitate updates as required
• Provide coaching to QCTS scientists and develop and contribute to their technical development
• Lead training of new analytical methods and support QC analysts on execution, data analysis and technical review of data generated in GMP lab.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency
• Support onboarding and qualification of new instruments in cGMP laboratory environment.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

Pay Range:
The annual salary range for this position is $120,000-$160,000.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Genezen is hiring for an Automation Engineer in our Lexington, MA office. The position will be hired as an Engineer I, II or III dependent on experience level of the successful candidate. The Automation Engineer is responsible for the administration of all facilities and process automation.

JOB RESPONSIBILITIES

• Provides automation support and troubleshooting services to Genezen’s operational groups.
• Supports design, implementation, and commissioning/qualification of new automation systems.
• Provides budgetary and schedule estimates for all automation related projects.
• Leads automation specific projects to modify/improve equipment, facilities, and/or process controls with supervisory oversight.
• Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
• Develops test scripts, automation procedures, and specifications.
• Candidate will be required to carry a cellular phone and be on call to support manufacturing operations.

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

Compensation: 

The compensation range for this position is $65,000-$130,000 dependent upon experience level of the successful candidate. 

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl 

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

The incumbent is responsible for assisting in completion of all computer system validation project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, quality management system and current industry practices (includes standard operating procedures, technical reports and risk assessments).

ESSENTIAL JOB FUNCTIONS

• Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
• Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
• Investigates / troubleshoots validation problems.
• Support and/or initiate investigations into protocol non-conformances and site deviations.
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Provides input to standard operating procedures related to validation practices.
• Support the implementation of validation programs (e.g., requalification).
• Represent the validation department at team meetings or projects.
• Performs periodic reviews and ongoing support of validated systems post Go-Live.
• Perform revalidation and change control validation related activities.
• Ability to apply complex system validation principles to work assignments.
• Responsible for executing and reviewing control systems validation activities including projects associated with BMS, CMS, and other automation upgrades.
• Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
• Assist validation activities of cross functional teams that include technical functions such as Quality Control, Information Systems, Manufacturing and QA Engineering.

SPECIAL WORK REQUIREMENTS

• Fully onsite position
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

Pay Range:
The annual salary range for this position based upon level hired is: $90,000-$130,000

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

Pay Range:
The annual salary range for this position based upon level hired is: $85,000-$130,000
      

JOB SUMMARY

The Quality Control Technical Services (QCTS) team manages the lifecycle of analytical methods, including method transfer and validation, stability programs, reference standards, critical reagents, product specifications, and computer systems validation. The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures regulatory compliance, analytical excellence, and effective cross-functional collaboration to maintain product quality throughout the product lifecycle

ESSENTIAL JOB FUNCTIONS 

• Govern the Stability Program on behalf of clients across all early phase, and commercial programs for DS, DP, and diluents 
• Ensure compliance with Quality Agreements and global regulatory expectations 
• Maintain and oversee the Stability Master Planner 
• Monitor and publish stability KPIs 
• Supervise, mentor, and develop team members. 
• Own quality documentation including deviations, CAPAs, and change controls related to stability 
• Manage the revision and approval SOPs, protocols, and reports 
• Conduct audits of stability studies and processes 
• Verify data for accuracy and compliance 
• Summarize and interpret stability data and generate stability trend analysis reports 
• Partner with cross-functional teams for execution of stability studies 
• Identify and implement operational improvements 

SPECIAL JOB REQUIREMENTS

• Proven leadership and cross-functional collaboration skills 
• Ability to manage competing priorities under pressure 
• Highly organized with strong problem-solving skills 
• Clear professional communication and presentation skills 
• Commitment to quality, integrity, and continuous improvement 
• Prior CDMO experience a plus 
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

EDUCATION

• Education Level: Master’s Degree in science-related field

ON-THE-JOB EXPERIENCE

• 8+ years of industry experience in CDMO 
• Experience managing stability programs for cell/gene therapy products 
• Strong understanding of cGMPs and global regulations 
• Experience managing deviations, CAPAs, and change controls 
• Experience with analytical methods such as potency assays, ELISA, ddPCR, qPCR, SEC-HPLC, and CE-SDS 

SKILLS/ABILITIES

• Prior experience working in a CDMO environment 
• 8+ years working in a Good Manufacturing Practices (GMP) environment 
• Subject matter expert in Good Documentation Practices (GDP) 
• Excellent computer literacy (MS Word, Excel, SmartSheets) 
• Excellent project management tools (MS project, SmartSheets) 
• Excellent executive communication skills, both written and oral 

PAY RANGE:
The annual salary range for this position is $130,000-$150,000.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into Manufacturing.

This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 2:00-10:30pm. The Supervisor will report to the Director of Manufacturing and Compliance.

ESSENTIAL JOB FUNCTIONS

• Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
• Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow up on work orders
• Communicate/ coordinate day’s scheduling and staffing plan
• Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
• Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Identify and support process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, take action on safety issues and risks
• Ensure that the department is in a continuous state of readiness for production and GMP audits.
• When needed, independently perform manufacturing of client's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.
• Oversee external GMP cleaning team's training and activities to ensure compliance with internal procedures.

JOB QUALIFICATIONS

• Prior leadership experience in GMP manufacturing facility
• Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
• Experience completing moderate to complex schedules
• Hands -on experience in writing and reviewing the documentation
• Experience in (bio)-manufacturing unit operations
• Good writing and oral communication skills
• The work schedule may require adjustments to support production activities

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

KNOWLEDGE, SKILLS AND EXPERIENCE

Compensation: 

The compensation range for this position is $105,000-$130,000 dependent upon experience level of the successful candidate. 

Work Environment:

• Regularly sit for long periods of time

Movement:

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting:

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision:

• Frequently utilize close vision and the ability to adjust focus

Communication:

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into Manufacturing.

This position is located in Lexington, MA and will report to the Manufacturing Manager.

ESSENTIAL JOB FUNCTIONS

• Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
• Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow up on work orders
• Communicate/ coordinate day’s scheduling and staffing plan
• Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
• Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Identify and support process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, take action on safety issues and risks
• Ensure that the department is in a continuous state of readiness for production and GMP audits.
• When needed, independently perform manufacturing of client's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.

JOB QUALIFICATIONS

• Prior leadership experience in GMP manufacturing facility
• Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
• Experience completing moderate to complex schedules
• Hands -on experience in writing and reviewing the documentation
• Experience in (bio)-manufacturing unit operations
• Good writing and oral communication skills
• The work schedule may require adjustments to support production activities

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

KNOWLEDGE, SKILLS AND EXPERIENCE

Compensation: 

The compensation range for this position is $105,000-$130,000 dependent upon experience level of the successful candidate. 

Work Environment:

• Regularly sit for long periods of time

Movement:

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting:

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision:

• Frequently utilize close vision and the ability to adjust focus

Communication:

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Work closely with the Commercial team to implement Genezen’s overall business development strategy.  That includes identifying and engaging new prospective CDMO clients, coordinating client visits and proposals, negotiating agreements, maintaining a relationship with current clients, and achieving sales objectives. This role requires a thorough understanding of viral vector development, manufacture and regulations used for gene therapy and gene modified cell therapies, as well as a demonstrated ability to influence positive outcomes without direct reporting authority.

ESSENTIAL JOB FUNCTIONS

• Understand the overarching business development strategy, sales processes, structure, and desired customer experience  
• Identify and engage with new prospective clients using sources such as databases, publications, market analysis, trade shows, and contacts 
• Generate new leads, contact decision-makers, and screen and qualify potential new business opportunities 
• Lead and work closely with the commercial and technical teams to progress potential customers through the sales process (technical calls, RFP, proposals, visits, contracting, etc.) 
• Lead customer meetings/business due diligence evaluations  
• Advise on proposal generation for assigned opportunities and accounts, including detailed RFP responses and proposal development, including inputs from scientific and operations teams 
• Work with commercial leadership to drive negotiation of agreements and achieve sales objectives 
• Document pipeline effectively in CRM, maintain prospect databases, and provide forecasting data 
• Contribute to the implementation of marketing initiatives, including providing market information, distributing materials, and attending trade shows 
• Monitor and evaluate industry trends and customer drivers as well as internal capabilities and technologies 
• Demonstrate exemplary skills in leadership, communication, and account/relationship management while maintaining extremely high quality and efficiency standards

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs, including flexibility for different time zones 
• Criminal background check required 
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PAY RANGE: The annual salary range for this position is Base: $165,000-$185,000. In addition to base, is inclusive of a robust commission-based incentive plan.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment
Regularly sit for long periods of time

Movement
Repeated hand movements, typing, use of keyboard and mouse
Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting
Frequently lift and/or move up to 10 pounds
Occasionally lift and/or move up to 25 pounds

Vision
Frequently utilize close vision and the ability to adjust focus

Communication
Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.

With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. 

This position is located in Lexington, MA and reports to the MFG Supervisor.

ESSENTIAL JOB FUNCTIONS

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.

Primary responsibilities include the following:

• Attend daily meetings including shift hand off and ensure relevant information is shared between shifts.
• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state 
• Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
• Demonstrating general knowledge of aseptic techniques 
• Perform troubleshooting activities according to SOPs 
• Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed.
• Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms   
• Perform page reviews in BPRs, SLRs, Logbooks, and Forms  
• Carry out work in a safe manner, notifying management of safety issues and risks 
• Maintain up-to-date training folder for applicable processes 
• Required to work holidays and overtime as needed to support the manufacturing process

This individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment 
• Perform standardization of equipment 
• Support product change over activities 
• Support equipment and process qualifications if needed 
• Escalate work requests to Senior or Lead Technicians for submission in work request management system 

Staff Technical Training and Development:

• Propose continuous improvement, process, and human performance document revisions
• Escalate and contributes to process improvement and manufacturing Continuous Improvement items.
• Develop and maintain personal development plan
• Provide annual performance self-assessment

SPECIAL JOB REQUIREMENTS

• Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization  
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures  
• Hands-on experience in writing and reviewing documentation  
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Good writing and oral communication skills  
• Applies experience and skills to complete assigned work within own area of expertise
• Works within standard operating procedures and/or scientific methods
• Comfortably able to lift up to 40lbs  
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 20 pounds
• Rarely lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

The QC Analyst temporary role will be responsible for routine and non-routine QC testing within the Bioassay team within a GMP laboratory.  This is a 2^nd shift, full on-site, position (1 – 9.30pm) based at Genezen’s new state-of-the-art facility in Lexington, MA.  This role supports daily operations within the Quality Control group through execution of cell-based testing, routine lab support and working within Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Support outside of standard shift hours is required occasionally and the initial training period will be on first shift. All activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures. 

ESSENTIAL JOB FUNCTIONS

• Perform routine/non-routine cell-based testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, ddPCR, cell culture, ELISA)
• Perform peer review as SME of assay data with minimal errors. 
• Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required. 
• Review/generate protocols and reports, as required. 
• Establish, revise, review and maintain standard operating procedures. 
• Promptly and proactively communicates gaps to leadership
• Work as an active member of internal/cross-functional teams
• Train other analysts, as required. 

SPECIAL JOB REQUIREMENTS

• Strong understanding of GxP regulations, ability to apply to any situation, and identify deficiencies w/ some guidance.   
• Adaptability required as work schedule may change based on business needs.
• Criminal background check required (completion by staffing agency satisfies this requirement).
• Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

The incumbent is responsible for assisting the Validation manager in completion of all project milestones. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, process validation, and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments). Duties require some knowledge in the pharma/biotech field.

**This position is onsite 5 days per week in our Lexington, MA office

JOB RESPONSIBILITIES

• Perform hands on execution of site Re-Qualifications on equipment, utilities, controlled temperature units, and Media Fills. 
• Support efforts in developing remediation for follow-up and emergency requalification work.
• Familiarity with GE Kaye Validator and/or lives data acquisition systems.   
• Generates validation protocols, executes protocols, completes data analysis and writes final reports. 
• Perform calibrations on thermocouples with data loggers in a GMP/GXP environment.
• Participate in peer review and approval of validation documentation.
• Works in close collaboration with Manufacturing, Facilities, Supply Chain, Quality Control, and Quality Assurance teams to complete qualification responsibilities.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

Pay Range:
The hourly compensation range for this position is $27/hr-$38/hr.

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand, sit, use hands to finger, handle or feed; reach with hands and arms
• Occasionally required to walk, climb or balance, and stoop, kneel, crouch or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone, and e-mail

JOB SUMMARY

The Lead, Quality Control Technical Services (QCTS) – Data Integrity is responsible for ensuring that QC laboratory systems, instruments, software, and associated data workflows meet regulatory expectations for data integrity and GxP compliance. This role provides expert oversight and support across QC laboratory for computerized system implementation, instrument qualification, assay data workflows, software validation, and data governance activities. The lead partners closely with QC operations, Validation, IT, and system owners to ensure that QC systems are designed and maintained, and monitored in alignment with 21 CFR Part 11 and EU Annex 11, ALCOA+ principles, and corporate data integrity standards.  The role supports audits and inspections, authors technical documentation, resolves data-related issues, and contributes leadership through scientific and systems expertise.

ESSENTIAL JOB FUNCTIONS 

• Serve as the QCTS Data Integrity and Computerized System Validation SME, ensuring QC laboratory systems comply with 21 CFR part 11, EU Annex 11 and internal DI policies. 
• Provide expertise and support for QC computerized systems, including instrument software, standalone analytical instruments, and data acquisition/processing tools, including Excel spreadsheets.
• Partner with QC labs leads, system owners, Validation, and IT to ensure robust lifecycle management of QC systems, including system qualification, validation, periodic review, and configuration controls.
• Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment.
• Lead implementation of change management of QC instruments, software upgrades, and new laboratory technologies to ensure readiness for GMP use.
• Maintain and improve data integrity practices within the QC function, including data review workflows, audit trails, user access, data storage, and backup/restore procedures.
• Support QC investigations (deviations, OOS/OOT, CAPAs) involving data integrity, system performance, or data workflow failures; provide technical root-cause contributions.
• Lead authoring and maintenance of QCTS procedures, work instructions, validation protocol, validation summary reports, and guidance documents relating to computerized systems, instrument qualification (IOQ, PQ), and data integrity.
• Coordinate with external qualified service providers to ensure QC systems are validated.
• Support internal and external audits/inspections as the QCTS Data Integrity SME, providing evidence for QC systems, validation documentation, and data governance controls.
• Deliver training, guidance, and technical mentorship to QC analysts and system users to strengthen data integrity awareness and consistent system usage across QC.  

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

Pay Range:
The annual salary range for this position is $110,000-$150,000.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

•  Regularly sit for long periods of time 

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

•  Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

•  Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail  

JOB SUMMARY

The Sr. Program Manager supports client programs through Process Development and into GMP Manufacturing of gene therapy viral vectors. The Sr. PM is well-versed in contract clinical manufacturing and effectively delivering client projects in a fast-paced environment. The Sr. Program Manager will act as the primary contact between clients, Genezen project team members, and functional groups to track progress and ensure the delivery of quality products and services. They will be responsible for developing, tracking, and reporting on the projects. They will effectively monitor and present project updates to relevant stakeholders, clients, and project team members.

ESSENTIAL JOB FUNCTIONS

• Deliver client satisfaction through timely, effective communication and facilitation of expectations with stakeholders
• Prepare detailed project schedules, including identification of major milestones for overseeing, controlling, communicating, and managing all activities required to complete client projects
• Monitor projects and help resolve issues or escalate appropriately to ensure on time delivery of all milestones and help identify risk mitigation plans
• Organize, set agenda for, and lead meetings with clients and internal teams to facilitate project completion
• Ensure that project deliverables are client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements
• Deliver project status updates to team members and clients during all stages of the project, manage expectations, and escalate risk immediately
• Build strong relationships with clients and collaborate with business development to obtain new business opportunities from existing clients
• Monitor project costs and prepare regular project updates with management and clients
• Support company financial goals and objectives by supporting forecasting processes, assuring timely invoicing of project milestones, and supporting finance department in resolving disputes related to accounts receivable from clients
• Identify appropriate applications and methods in managing projects
• Proactively suggest improvements to existing processes and think creatively to promote new ideas that will benefit the team and our overall efforts

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs, including flexibility for different time zones
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment
Regularly sit for long periods of time

Movement
Repeated hand movements, typing, use of keyboard and mouse
Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting
Frequently lift and/or move up to 10 pounds
Occasionally lift and/or move up to 25 pounds

Vision
Frequently utilize close vision and the ability to adjust focus

Communication
Frequently required to communicate by talking, hearing, using telephone and e-mail

Pay Range:
The annual salary range for this position is $140,000-$175,000