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Quality Control Scientist I
2 months ago
About Forge Biologics
Forge Biologics is at the forefront of making transformative gene therapies accessible to patients in need. We work closely with pioneers in the gene therapy sector to expedite the development and production of innovative medical solutions. Our commitment to patients drives us to establish new collaborations and frameworks to ensure these therapies are delivered effectively.
Team Dynamics
The Quality Control team plays a crucial role in ensuring the safety and effectiveness of our gene therapies through meticulous analytical evaluations. This team is dedicated to adhering to regulatory standards and performing thorough assessments on AAV gene therapy products to guarantee the highest quality of care.
Role Responsibilities
The Scientist I, Quality Control (Analytical) will spearhead method development and validation initiatives, execute advanced testing protocols, and mentor junior personnel. This position presents an excellent opportunity for professional advancement within the gene therapy domain and allows for significant contributions to client-focused gene therapy projects.
Key Responsibilities Include:
- Conducting comprehensive testing on AAV-based therapeutic candidates sourced from diverse laboratories.
- Performing sophisticated analytical assessments, including qPCR, ELISA, SDS-PAGE, and HPLC, to determine product quality and safety.
- Assisting in process transfer activities and acting as a Subject Matter Expert (SME) to resolve process-related issues.
- Maintaining meticulous records of experimental procedures in accordance with Good Documentation Practices (GDP).
- Coordinating sample management for contract testing and ensuring accurate documentation.
- Contributing to the formulation and validation of novel analytical methodologies.
- Providing mentorship and support to junior team members.
Qualifications and Skills
- Bachelor's Degree in Molecular Biology, Biotechnology, Biochemistry, or a related discipline.
- Experience with mass spectrometry analysis of biological molecules.
- In-depth knowledge of HPLC, LC-MS, cell-based assays, PCR, ELISA, and other analytical methodologies.
- Demonstrated capability to execute and refine analytical assays.
Work Environment
This job description outlines the primary responsibilities and may evolve over time.
Forge Biologics is dedicated to fostering diversity and creating an inclusive work environment. We offer equal employment opportunities for all individuals, irrespective of race, color, religion, age, sex, national origin, disability status, genetics, or any other characteristic protected by law.
Company Culture
At Forge, our core values—Hardworking, Open, Purpose-Driven, and Engaged—guide our efforts in developing gene therapies and positively impacting patients' lives.
Employee Benefits
- Comprehensive Health, Dental, and Vision insurance with 90% of premiums covered for employees and their dependents.
- Unlimited Paid Time Off (PTO) and 14 paid company holidays.
- Annual bonus, equity-incentive plan, and 401(K) company matching.
- 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.
