Director, Formulation Development

Proclinical is currently recruiting for a Director of Formulation Development with a leading biopharmaceutical company located in New York, NY. As the Director, you will be responsible for managing the analytical aspect of portfolio projects with the responsibilities to serve as a formulation development and drug product subject matter expert.

Job Responsibilities:

• Develop drug product formulation and manufacturing processes for new or existing chemical entities in pre-clinical and clinical programs with focus on formulation process design, technology selection, process development, process data analysis, fundamental process understanding, and drug product characterization.
• Responsible for the design, planning, execution and delivery of formulation and process development studies, toxicology study/clinical supplies, process performance qualification and technology transfer for oral and sterile liquid and/or lyophilized parenteral drug products for small and large molecules.
• Apply QbD approach to improve the drug formulation and manufacturing process to effect consistent product quality.
• Support Contract Service Provider selection due diligence process.
• Direct outsourced drug product development and execution at CDMOs including request for proposal preparation, proposal review, monitor project activities, provide progress report and troubleshooting.
• Provide on-site presence at CDMOs as needed to achieve objectives
• Prepare, review, and approve drug product development and validation documentation including technical agreements, protocols, batch records, reports, change controls, deviations, CAPAs, and risk assessments.
• In collaboration with regulatory, author relevant Chemistry, Manufacturing and Controls (CMC) sections for drug products and address Regulatory reviewer comments with data supporting responses to enable accurate and timely registrational submission.
• Collaborate with Quality in developing stability studies for drug product intermediate and finished drug product to support shelf-life.
• Collaborate with Analytical in developing Drug Product Specifications justifications and testing requirements.
• Flexibility to travel up to 15% domestic/international (post-COVID).

Skills and Requirements:

• Ph.D. or M.S. in Chemistry with 15+ years of related pharmaceutical development experience.
• Strong scientific background and in-depth working knowledge of oral solid/liquid dosage form development (small molecule), manufacturing process unit operations, scale-up, technology transfer, and in process control testing. Knowledge in biologic product formulation is a plus.
• Ability to understand complex processes, identify knowledge gaps and propose efficient and effective solutions to issues.
• Ability to assess third party capabilities and facilities in support of contract development and manufacturing organization (CDMO) selection is a plus.
• Demonstrated skills of applying fundamental scientific and engineering principles to formulation design, development and process understanding.
• Up to date knowledge of ICH guidelines and FDA Guidance related to Pharmaceutical development, manufacturing, and stability of drug product.
• Experience in actively managing outsourcing to contract development and manufacturing organizations.
• Ability to work independently in a cross-functional team environment.
• Ability to manage multiple priorities and operate effectively.
• Strong technical writing and oral communication skills.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 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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