Director, Quality Control

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

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
BS in a scientific/technical discipline	Essential
MS in a scientific/technical discipline	Preferred
ON-THE-JOB EXPERIENCE
7+ years of experience in a QC leadership position within the biological industry	Essential
Proven technical leadership and experience in bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays.	Essential
Familiarity with viral vector release assays	Preferred
Proven lab operations management experience	Preferred
3+ years of cGXP experience	Preferred
SKILLS / ABILITIES
Ability to maintain multiple projects and timelines	Essential
Strong people leadership skills	Essential

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