Description
Responsibilities
- Provide technical oversight and strategic input for pilot plant and manufacturing activities
- Lead technology transfer from process development to manufacturing w
- Preparation of CMC content for technology transfer, and manufacturing support
- Organize daily operations for a team of engineers, scientists and technical SMEs
- Establish and maintain an understanding of current trends in manufacture, scale-up of technologies, and best practices in technology transfer
- Understand statistical methods of process validation, process trending, and experimental design using design of experiments (DoE)
- Support scale-up of new innovative and global regulatory processes
- Development of product and processes to meet our global strategy
- Provide manufacturing technical support, including process troubleshooting, root cause analysis, and investigation on process and/or quality discrepancies and deviations during GMP production
- Work with cross functional teams including Research, Regulatory and Clinical to establish manufacturing plans and deliver on the established Production Operation’s annual goals and objectives
- Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation
- Manage daily production operations in early development builds, early and late phase clinical trials, and commercial manufacturing as needed
- Establish and revise Batch Records, Standard Operating Procedures and other operational documents as needed, review Qualification/Validation protocols and reports, and other essential cGMP documents
- Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion, and with Supply Chain to manage raw materials and deliver product per the timelines
Qualifications
- Bachelor’s Degree in Scientific, Engineering or related discipline
- 3 – 5 years of experience in pharmaceutical drug product manufacturing with specific responsibilities in supervision and manufacturing of product for clinical trials or equivalent experience
- In-depth knowledge of cGLPs and cGMPs
- Experience writing and developing SOPs and other regulatory documentation
- Build effective manufacturing team
- Must be able to work in a cleanroom environment.
