The Director of Formulation Development will report to the Senior Director of CMC and will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials and NDA readiness activities. This position will be required to work independently and have experience managing outsourced drug product manufacturing activities at contract manufacturing sites.
- Oversight and direction of GMP production activities at the external CMOs for manufacturing drug product for supplying clinical trials
- Support QA by participating in on-site audits as a technical expert.
- Review and approve master batch records, executed batch records, manufacturing deviations and investigations
- Provide on-site technical support as needed to oversee various manufacturing/scale up/validation activities. Provide technical expertise to trouble-shoot manufacturing/packaging process issues
- Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols
- Prepare technical reports in support of planned regulatory submissions.
- Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines
- Assist in supply chain logistics for drug product manufacturing activities
- Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance, Quality Assurance, Analytical Development and Quality Control)
- Advanced degree (MS or PhD) in pharmaceutics, pharmaceutical science, chemical engineering, or other related scientific discipline
- 10+ years of hands-on experience with increasing responsibility in solid oral dosage manufacturing process development
- Experience with commercial manufacturing of solid oral dose a plus
- Expertise using DOE to screen, characterize, and optimize manufacturing process parameters
- Experience in late stage drug product process development including identification of CMAs and CPPs and their relationship to CQAs. Work cross functionally in the development of appropriate control strategies.
- Experience with experimental design and statistical analysis
- Demonstrated experience working with statistical software packages JMP, SAS, Design Expert or similar
- Drug Product Validation experience
- A robust understanding of quality requirements for GMP drug product manufacturing as well as ICH guidance documents
- Experience managing engineering challenges of large scale solid oral dosage processes involved in manufacturing, such as blending, granulation, compression and packaging
- Experience in sterile intravenous formulation development and manufacturing
- Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA)
- Strong understanding of pharmaceutical development, quality and regulatory issues
- Hands-on GMP experience with late phase of drug product development, as well as in-depth knowledge and full understanding of GMP requirements. NDA authoring experience a plus
- Ability to manage tasks (directly and indirectly) and variable workloads with demanding timelines
- Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution
- Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
- Proficiency with Microsoft software (Word / Excel / PowerPoint)
Position requires 20% travel. Must have the ability to travel internationally.