Our client is hiring an Associate Director to build an MS&T group at their commercial manufacturing facility. This is an opportunity to work with an established biopharma company that is on the brink of a few launches.
Responsibilities and Job Duties
- Leads investigations of deviations and develops and implements corrective actions at cGMP manufacturing facilities to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
- Performs detailed data analyses and root cause analyses to identify solutions to complex problems and monitor and control process performance. Perform fit-to-plant projections and plan for new processes and implement processes in multiple manufacturing facilities.
- Champions and implements change controls, leads selection of new equipment and materials, and manages their implementation at manufacturing facilities to improve existing and new processes.
- Leads technology transfer activities to internal and external manufacturing sites and corporate partners and serves as technical expert in supporting manufacturing at CMOs. Engages with program managers to ensure projects are planned and executed appropriately to deliver to and meet the needs of our customers and the business. Provides input to technical development early in the process
Knowledge, Skills and Abilities
- In depth knowledge of large scale biologic, pharmaceutical manufacturing, current Good Manufacturing Practices and US/EU regulations and intermediate knowledge of statistical data analysis. Knowledge should include a combination of cell biology, protein chemistry, and aseptic processing technologies and include small scale (laboratory) experience.
- Demonstrated ability to set vision and direction for a team including setting expectations and accountability
- Excellent motivation and coaching skills and ability to communicate to the team how their roles fit into the overall drug development process and the impact their performance has on the company and patients
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
- Able to concisely communicate status, needs, forecasts, risks and timelines effectively to senior management
- Solid proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
Job Type: Full-time
Salary: $90,000.00 to $150,000.00 /year
- Management: 3 years
- Tech Services: 8 years
Required work authorization: