QC Senior/Principal Scientist, Analytical Method Validation

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.

• 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.

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

Ph.D or MS in Molecular Biology/Biochemistry or other related Life Sciences

Minimum 8 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.

Prior experience with analytical method validations, analytical data trending/statistical analysis

Understanding of QC instrument qualification is preferred.

Thorough understanding of industry testing requirements/standards

Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential.

Thorough understanding of industry testing requirements/standards related to gene/cell therapy products.

Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy.

Working knowledge of quality systems requirements

Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.)

Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities

Proven demonstration of technical writing skills such as protocol, reports, procedures etc.

Effective project management and presentation skills

Good/effective communication and organizational skills with the ability to work well with others and independently

Ability to work collaboratively with cross functional departments

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

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success. 

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. 

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.