Senior Scientist, Drug Product Development (Contract)

What you'll do:

• Demonstrates technical proficiency, cross-functional collaboration with External Manufacturing, Process Development, Analytical Development, Quality Control, and other relevant stakeholders to drive improvement, consistency and compliance for drug product manufacturing processes.
• Establish internal Drug Product Development capabilities including:
• Design and conduct experiments to develop stable and effective drug formulations, including selection of excipients, and compatibility studies.
• Conduct stability studies to assess the short- and long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
• Establish and qualify representative scale down models in support of drug product process design.
• Design drug product process characterization (PC) strategies, engage cross-functional SMEs and execute PC activities to enable BLA submission.
• Develop and scale-up manufacturing processes considering critical process parameters (CPPs) and critical quality attributes (CQAs). Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency.
• Provide support for drug product process technology transfer and GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, lead risk assessment and serve as person-in-plant as required.
• Manage, collaborate and provide scientific oversight of formulation and drug product process development and data generated by internal and contract labs.
• Must think critically, ability to work independently and awareness on when to seek guidance and have strong organizational and planning skills.
• Author and review technical development documents including study protocols, technical reports, and batch records.
• Provide direction and leadership to junior scientists.

About you:

• Ph.D. in Pharmaceutical Chemistry, Biochemistry, Chemistry, Chemical Engineering, Bioengineering or related discipline with 5-8 years of relevant experience in biologics or viral vector drug product development; or M.S. with 8-11 years of relevant experience. Job title is dependent on candidate’s experience level.
• Must have proven experience with formulation development, drug product process development and optimization, statistical design and analysis of experiment, managing CROs, tech transfer to CDMOs.
• Must have knowledge and hands-on experience with analytical instrumentation used in biologics/viral vector formulation and process development such as spectrometry, HPLC, CE, particle characterization techniques, calorimetry, light scattering etc.
• Experience with fill-finish processes, clinical compatibility studies, scale-up and/or technology transfer.
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
• Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.
• Must have excellent problem-solving skills, verbal and written communication skills.
• Ability to work in a dynamic environment, with a willingness to adapt to shifting priorities and tasks.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment.