Senior Quality Control Associate - Capsid ID

Rejuvenate Bio is using a convergent, multi-disciplinary approach, combining gene therapy, proprietary targets, and the animal health market to bring human age-related therapies to market. We are targeting the core drivers of chronic age-related diseases by unlocking the power of gene expression and epigenetic reprogramming to reverse pre-existing heart disease, metabolic disease, and kidney failure in humans.

Each therapy we’re developing has the potential for therapeutic impact across multiple disease indications, with each new piece of data validating the approach and increasing the value of each clinical program. This will allow us to rapidly expand each product into multiple indications. Additionally, our animal health programs provide an untapped market for early revenue and further validation for use in humans.

Senior Quality Control Associate

At Rejuvenate Bio, we aspire to treat aging and age-related diseases. We are a spinout from George Church's lab at Harvard Medical School and the Wyss Institute, and our goal is to treat pets and people with targeted gene therapies directed at curing specific disease states associated with old age that also have the potential to extend overall health and maximize lifespan. Our approach is pushing gene therapy beyond single gene disorders and has the potential to make a significant impact in age-related chronic conditions driving the bulk of healthcare spending.

Overview:

Rejuvenate Bio is looking for a highly motivated individual to join our energetic Quality Control team and accelerate the development of our therapies. The Senior QC Associate will directly support efforts to drive forward our future commercial offerings by developing our GMP process. This position will be responsible for the development, execution, and analysis of analytical assays supporting Process Development and Manufacturing. While this role is primarily lab-based, responsibilities also include initiating quality events such as Out of Specifications, assisting in PQs of newly developed SOPs, and performing QC data review of reports for accuracy, specification approval, and compliance. This role reports directly to the Sr. Director of CMC.

Responsibilities:

• Develops and optimizes gene therapy product characterization assays for analytical method transfer to support process development and manufacturing including (but not limited to) drug product physicochemical characterization, capsid ID, vector genome titer via ddPCR, cell-based, and immunoassays.
• Act as SME in tech transfer of analytical methods, protocols/procedures and know-how from internal labs to external labs.
• Assess biodistribution of our therapeutic entities, including PCR/protein expression of AAV capsids and associated transgenes.
• Review and approval of ancillary documentation associated with laboratory testing including logbooks, forms, raw data, etc. with external vendors and internal QC team.
• Adhering to Good Manufacturing Practices and GxP guidelines when performing QC testing.
• Screening and analyzed cell lines through cell-based assay test such as ELISA.
• Works with QA to close out quality events related to release testing or protocol development at external labs.
• Assist with the review of laboratory records and associated documentation required for lot release.
• Execute qualification protocol method of various assays.
• Work with CTL and CMO to coordinate shipping and testing of samples for lot release, investigations, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT.
• Responsible for the accurate, timely and compliant execution of assigned projects, related documentation, and any other tasks as assigned by management.

• Bachelor's degree in Biology, Chemistry, or relevant Life Sciences field.
• 4+ years of relevant quality control experience in the Biotech or pharmaceutical industry, with at least 1 year in Gene Therapy.
• Experience with novel methods in AAV characterization (e.g. ddPCR, DLS, AUC, NGS, CE-SDS, mass spec etc.)
• Knowledge of cell-based methods associated with bioanalytical analytical method development (e.g. empty/full, viral transduction, and ELISA methods).
• Knowledge of GLP and GMP requirements as they pertain to gene therapy process development and Quality Control (QC) testing protocols to and from CDMOs.
• Experience performing QC testing while adhering to Good Manufacturing Practices and GxP guidelines.
• Working knowledge of industry guideline including GxP, cGMPS, ICH, CFR, and global regulations as appropriate.
• Experience with Quality Systems (change control, deviation, and investigation) is a plus.
• Previous experience training new hires and authoring or editing SOPs for Quality Control.

Compensation: $90,000 - $130,000 DOE

EEO Statement

Rejuvenate Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Rejuvenate Bio is an E-Verify Employer in the United States. All your information will be kept confidential according to EEO guidelines. 

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Position is primarily sedentary, and employee may be required to sit for extended periods of time.
• Standing, walking and meeting activities are required frequently throughout the workday.
• Must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.).
• Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Must be able to lift and carry up to 25 lbs
• Must be able to talk, listen and speak clearly on telephone

The health and safety of our employees and their families is a top priority. The company encourages employees to remain up-to-date on their COVID-19 vaccinations. Rejuvenate Bio, Inc. employees may be required, in the future, to be vaccinated or have an approved disability/medical or religious accommodation.