To be a part of a developing oncology company, we're looking for a motivated professional with significant upstream process development and manufacturing experience with biologics.
They will contribute to the development and implementation of operational plans to achieve project timeframes and the company's commercial objectives in a highly collaborative team environment.
- The successful candidate's responsibilities include the technical oversight and management of outsourced upstream process activities such as cell line generation, cell culture optimization, validation, and upstream GMP manufacturing of monoclonal antibodies at top tier external contract development and manufacturing organizations (CDMO).
- They'll work with a number of internal departments, including downstream manufacturing, quality control, quality assurance, regulatory, and supply chain, to ensure that best practices are established and followed both at external contract manufacturing and testing labs and internally.
Specific responsibilities include:
- Manage all upstream process development, optimization, validation, and GMP manufacturing activities for clinical supply at top tier CDMOs from launch to BLA.
- Co-author batch records, validation protocols/reports in collaboration with the CDMO
- Use creative problem-solving skills to independently troubleshoot experimental challenges - interpret data, define problems, establish facts, draw valid conclusions and make decisions
- Assist with the trending of process development, validation, and manufacturing data for continuous process improvement
- Manage drug supply/demand forecasting estimates
- Manage operational budget and timelines
- Participate in batch release with QA and QC including the review of batch records and supportive data
- Provide technical input for the resolution of investigations, deviations, out-of-specification/out-of-trend, change control, and CAPAs at contract sites
- Author relevant sections of IND/IMPD regulatory filings
Education / Experience / Skills:
- S., M.S. or Ph.D. in cell biology, chemical engineering, bioengineering, biochemistry, or equivalent.
- 10+ years (depending on education) of progressive hands-on experience in upstream process development and GMP manufacturing of monoclonal antibodies in the pharmaceutical/biotech industry
- Substantial experience with managing external CDMOs
- Process validation experience in support of late-stage clinical programs preferred (DoE, IQ/OQ/PQ)
- Experience with cell line development and cell banking
- Advanced understanding of the application of FDA regulations and ICH guidelines from early development through commercial product
- Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
- Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross functional personnel at all levels