Formulation Development Cmc Jobs in Pennsylvania

Scientist/Senior Scientist - Cell Bioassay/Potency

Title: Scientist/Sr. Scientist, Cell Bioassay/Potency

Location: Exton, PA

Reports to: Sr Director BGC Therapy Operations

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

The Scientist/ Sr. Scientist will be a leading member in the Analytical Technologies group responsible for bioassay development, validation, transfer, and execution at Gritstone Bio. The bioassays include cell-based potency assay, ELISA, PCR-based assays, and virus infectivity assays, etc., that are used to support product characterization, release, stability study in GMP setting as well as other research projects for process, formulation, and manufacturing development. This position will contribute to the strategy of selecting and implementing bioassays to ensure our products are comprehensively characterized and under superb quality control. With dedication to troubleshooting and optimizing assays on bench, this position may lead a small group to achieve department goals. Excellent training and background in biological sciences, such as cell biology, molecular biology, biochemistry, immunology, virology, etc., is required.

Roles & Responsibilities:

• Develop and apply molecular biological methods, immunoassays, and other state of the art analytical technologies to analyze and characterize cell and gene products, biotherapeutic proteins, their conjugates, and variants.
• Independently select, develop, validate, and transfer biological assays including cell-based potency assays, ELIZA, qPCR-based assays, virus infectivity assays, etc.
• Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across varieties of biological products.
• Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
• Prepare and review notebooks in compliance with Frontage CMC SOPs.
• Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.
• Manage projects from initiation to completion and ensure the projects are on time and meeting pre-established quality standards.
• Author method SOPs, development reports, qualification/validation reports to support method transfer to GMP QC
• Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release and stability testing of drug substance and drug products.
• Development and optimization of analytical methods, in accordance with client requirements and associated protocol and procedures

Education, Experience & Skills Required:

Educational/Training Requirement:

• PhD, MS or BS in Biological Science, Biochemical Engineering, or related discipline.

Experience:

• PhD in Biological Science, Biochemical Engineering, or related discipline with 0-2 years’ relevant industrial GMP testing or analytical development experience for biologics or cell and gene therapy products, or
• MS with 2-4 years’ GMP testing or analytical development experience for biologics or cell and gene therapy products, or
• BS with 3-5 years’ GMP testing or analytical development experience for biologics or cell and gene therapy products.
• Excellent organization and planning skills.
• Experience in virus-vector based biotechnology or virology in general is preferred but not required.
• Excellent communication skills, with the ability to work with individuals in wide ranging teams at all levels and the ability to lead and influence.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.