QC Senior/Principal Scientist, Analytical Method Validation

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

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

EDUCATION / CERTIFICATIONS / LICENSES

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

ON-THE-JOB EXPERIENCE

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

SKILLS / ABILITIES

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

• 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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

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

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

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

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

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

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure

Paid sick time

10 observed holidays + 2 floating holiday + 1 volunteer day

401(k) plan with company match up to 6% of salary

Share Appreciation Rights

Choice of