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Scientist I, Quality Assurance and Control
2 months ago
About Forge Biologics
Forge Biologics is committed to enhancing access to transformative gene therapies, transitioning innovative concepts into reality. We partner with pioneers in the gene therapy sector to expedite the development and production of groundbreaking medicines. Our focus on patient needs drives us to establish new collaborations and frameworks to ensure these vital therapies reach those who require them.
Team Insights
The Quality Control division at Forge plays a crucial role in ensuring the safety and effectiveness of our gene therapies through meticulous analytical evaluations. This team is dedicated to upholding regulatory standards and performing thorough assessments on AAV gene therapy products to deliver superior treatments.
Position Summary
The Scientist I, Quality Control (Analytical) will spearhead method development and validation initiatives, execute advanced testing protocols, and mentor junior personnel. This position presents a pathway for professional advancement within the gene therapy industry and offers the chance to make a significant impact on client gene therapy projects.
Key Responsibilities
- Conduct comprehensive testing on AAV-based therapeutic candidates from diverse laboratories.
- Perform sophisticated analytical evaluations, including qPCR, ELISA, SDS-PAGE, and HPLC, to assess product quality and safety.
- Assist in process transfer activities and act as a Subject Matter Expert (SME) to resolve process-related issues.
- Maintain thorough documentation of experimental procedures in accordance with Good Documentation Practices (GDP).
- Oversee sample coordination for contract testing and ensure accurate documentation.
- Contribute to the formulation and validation of novel analytical methods.
- Provide mentorship and support to junior team members.
Qualifications
- Bachelor's Degree in Molecular Biology, Biotechnology, Biochemistry, or a related discipline.
- Experience in mass spectrometry analysis of biological molecules.
- Advanced proficiency in HPLC, LC-MS, cell-based assays, PCR, ELISA, and other analytical methodologies.
- Demonstrated capability to execute and refine analytical assays.
Work Environment and Physical Requirements
This job description outlines the primary responsibilities and may evolve over time.
Forge Biologics is dedicated to fostering diversity and creating an inclusive workplace. We provide equal employment opportunities for all individuals without regard to race, color, religion, age, sex, national origin, disability status, genetics, or any other characteristic protected by law.
Life at Forge
At Forge, we are guided by our core values: Hardworking, Open, Purpose-Driven, and Engaged. These principles direct our efforts towards developing gene therapies and positively impacting patients' lives.
Employee Benefits
- Health, Dental, and Vision insurance with 90% of premiums covered for team members and dependents.
- Unlimited PTO and 14 paid company holidays.
- Annual bonus, equity-incentive plan, and 401(K) company match.
- Fully-stocked kitchen with complimentary food and beverages.
- 12 weeks of paid parental leave and additional discount programs.
- Employee Assistance Program and Wellness benefits.
- Resources for Professional and Personal development.
