Director, Formulation Development
Proclinical is currently recruiting for a Director of Formulation Development with a global biopharmaceutical company located in New York, NY. As the Director of Formulation Development, 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.
- 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
- PhD or MS 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 firstname.lastname@example.org.
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.