JOB SUMMARY

Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.

ESSENTIAL JOB FUNCTIONS

• Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
• Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
• Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
• Develop, implement and maintain an in-house isolates program
• Responsible for Disinfectant Efficacy Program
• Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
• Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Support the tech transfer of bioassays from clients to cGMP QC testing lab
• Represent QC Analytical and Microbiological in client meetings and programs
• Establish and maintain the stability program
• Oversee LIMS development, implementation, operation, troubleshooting and maintenance
• Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
• Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
• Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of cell and gene products
• Develop, implement and present metrics for monitoring of lab operations and stability program
• Participation in client audits and regulatory inspections as SME and development of responses to observations
• Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

 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
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

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
• 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

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

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 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