We are seeking an Analytical Sciences Associate to work within our expanding Analytical Sciences team at Encoded Therapeutics!
Responsibilities:- Perform routine analytical testing to support GMP release, stability, and product characterization programs, including cell-based potency assays, molecular assays (e.g., ddPCR), and/or biochemical assays (e.g., ELISA, CE, HPLC, Western blot), with primary depth in at least one assay category.
- Execute assays in accordance with approved SOPs, test methods, and protocols, ensuring compliance with GMP documentation practices and data integrity (ALCOA+) requirements.
- Review and verify analytical data for accuracy, completeness, and compliance with GMP documentation standards.
- Collaborate cross-functionally to support method qualification, validation, and transfer activities in accordance with ICH, USP, and GMP guidelines.
- Maintain laboratory and instrument readiness, including equipment calibration, maintenance tracking, reagent preparation, sample receipt and tracking, logbook documentation, and inventory management in compliance with GMP requirements.
- Collaborate cross-functionally with manufacturing and QA to support method transfer, technical assessments, and data quality.
- Support internal and external audits, regulatory inspections, and data requests as needed.
- Train and mentor other analysts as needed.
Requirements- Bachelor's or Master's degree in Molecular Biology, Cell Biology, Biochemistry, Biotechnology, or a related discipline.
- 3-8 years of relevant experience in Analytical Sciences or QC environment in the biopharmaceutical or gene therapy industry.
- Familiarity with GMP documentation practices, data integrity principles, and regulatory expectations for biologics or gene therapy products.
- Strong attention to detail, organizational skills, and ability to execute protocol-driven workflows in a regulated environment.
- Effective communication and ability to work collaboratively in cross-functional GMP teams.
- Hands-on experience in at least one of the following areas required, with working knowledge or exposure to others preferred: Cell-based potency assays, Molecular assays, or Biochemical assays (ELISA, CE, HPLC, Western blot).
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave: (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Stocked micro-kitchen with drinks and snacks
- Wellness Resources
Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.
