Associate Director, Biologic Formulation Development

Proclinical is seeking an Associate Director, Biologic Formulation Development for a cutting-edge biopharmaceutical company located in San Francisco, CA.

This individual will be responsible for parenteral drug product development from lead optimization to clinical development and through commercialization and should have experience in pre-formulation, formulation development, process selection and scale up, oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs).

Job Responsibilities:

• Experienced in formulation and process development of sterile, parenteral dosage form development from lab to commercialization (pre-filled syringe and lyophilized products)
• Experience in hydrogels, emulsions, suspensions, injectable depot, liposomes, microspheres, nano-suspensions is a plus.
• Experience in developing phase-appropriate drug product development plans and managing activities at partnering CDMOs.
• Knowledge of analytical methods supporting parenteral manufacturing required.
• Knowledge in pharmacokinetic data generation and interpretation preferred.
• Excellent communication skills (both verbal and technical) and interpersonal skills are required.

Skills and Requirements:

• 10+ years of experience in peptide, biologics or small molecule parenteral formulation development and manufacturing
• MS/PhD in Pharmaceutical Sciences
• Must have sound understanding of the principles and practices of pharmaceutical sciences and be able to integrate and apply this knowledge effectively to formulate new chemical entities.
• Working under general supervision, plans, designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug formulations.
• Applies formulation development principles and techniques to products and problems. Serves as person in plant during clinical trial material manufacturing and/or critical process development experiments.
• Works with the team to advance the development of state-of-the-art drug delivery techniques/devices.
• Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations.
• Represents pharmaceutical sciences in cross-functional team meetings.
• Authors relevant sections of regulatory dossier for IND/NDA and IMPD for submissions.
• Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
• Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
• Thinks critically and creatively and can work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• The ability to travel domestically and internationally is expected.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at +(1) 857-362-9542 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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