New York, NY 10001
Job DescriptionManage the analytical aspect of the portfolio projects with the responsibilities to serve as a formulation development and drug product subject matter expert
and to oversee the timely delivery of high-quality drug products that meet the established pre-clinical, clinical and commercial requirements.
- 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.
- 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.