Job Information
Vertex Pharmaceuticals Incorporated Associate Director, Formulation and Drug Product, Biologics in Seattle, Washington
Job Description General Summary: The Associate Director, Formulation and Drug Product for Biologics is a senior-level position responsible for leading the development of innovative formulations and drug delivery systems for biologic therapeutics. This role requires extensive expertise in protein chemistry, biophysics, and pharmaceutical sciences to optimize the stability, efficacy, and manufacturability of complex biological molecules. The ideal candidate will have a proven track record in designing and implementing formulation strategies from Phase 1 through commercialization for a diverse range of biologics, including Fc-conjugates, monoclonal antibodies, peptides, and recombinant proteins. This role works in a multidisciplinary cross-functional environment. Key Duties and Responsibilities: Lead Formulation Development: Oversee the design and execution of formulation strategies for biologic drug products from Phase 1 through commercialization based on Quality by Design principles, ensuring stability, efficacy, and manufacturability in different container closure systems and storage conditions. Project Management: Manage drug product development projects, including timeline and resource planning, to ensure milestones and deliverables are met efficiently. Technical Leadership: Serve as the principal technical lead, providing expertise in protein chemistry, biophysics, and pharmaceutical sciences to tackle such challenges as high concentration formulations, post-translational modifications, lyophilization, excipient stability, and particulate formation. Collaborate within CMC teams as the Formulation lead and actively contribute to deliverables and engage in team discussion on issue resolution. Serve as CMC project lead as needed. Process Development: Design and optimize aseptic filling processes and control strategies for drug product, including process characterization, PPQ, scale-up, and technology transfer to internal and external manufacturing sites. Work closely with Contract Development and Manufacturing Organizations (CDMOs) to design processes needed to perform aseptic filling operations in a GMP environment. Communication and Reporting: Effectively communicate development plans, risks, and mitigation strategies to stakeholders and line management, and author scientific publications, patents, and regulatory documents. Data Analysis and Interpretation: Conduct and interpret scientific experiments, utilizing statistical tools and data visualization techniques to inform decision-making and optimize formulations. Innovation and Improvement: Initiate and support scientific initiatives to drive innovation, enhance capabilities, and improve business processes within the formulation and drug product development domain. Mentorship and Training: Mentor and train junior scientists and engineers, fostering a collaborative and innovative work environment. Education & Experience Bachelor's, master's or doctoral degree in pharmaceutical sciences, chemistry, chemical engineering, or materials sciences. 8+ years of relevant pharmaceutical development experience in a biotech setting with a proven track record of advancing biological therapeutics into the clinic. Working knowledge of drug product formulation, fill/finish development and PIP for protein-based products. Working knowledge and hands-on experience with analytical techniques such as SEC, cIEF, CEX, CE, Viscosity, MS, BMI, FMM, HIAC, Visual Inspection, CCIT, etc. Working knowledge and hands-on experience with high throughput formulation screening techniques such as differential scanning fluorimetry, differential scanning calorimetry, cloud point temperature by PEG separation, and diffusion interaction parameter (kD) by dynamic light scattering, etc. Experience with writing and filing regulatory documents including IND's and BLA's