- Seeking a driven individual with extensive downstream process development and manufacturing experience with biologics to be a valuable member of a rising oncology company.
- They will work with a highly collaborative team environment to aid in developing and applying operational plans to meet project timelines and the company's business objectives.
- The candidate will be responsible for the technical oversight and management of external upstream process activities including cell line generation, cell culture optimization, validation, and upstream GMP manufacturing of monoclonal antibodies at premier external contract development and manufacturing organizations (CDMO).
- They will cooperate with various internal functions including downstream manufacturing, quality assurance, quality control, supply chain, and regulatory to ensure optimal practices are applied and followed at outsourced contract manufacturing and testing labs, and internally.
Specific responsibilities include:
- Manage entirety of upstream process development, validation, optimization, and GMP manufacturing activities at premier CDMOs for clinical supply through launch/BLA
- Co-author batch records, validation protocols/reports in cooperation with the CDMO
- Use creative problem-solving skills to independently troubleshoot experimental obstacles: interpret data, define problems, establish facts, draw defensible conclusions and make decisions
- Assist with the trending of process development, validation, and manufacturing data for improvement of processes
- Manage drug supply/demand forecasting estimates
- Oversee operational timelines and budgets
- 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.
- 6-10+ years (depending on education) of progressive practical experience in upstream process development and GMP manufacturing of monoclonal antibodies in the pharmaceutical/biotech industry
- Substantial experience with managing external contract manufacturers is desired
- Process validation experience in support of late stage clinical programs preferred (DoE, IQ/OQ/PQ)
- Experience with cell banking and cell line development
- Advanced understanding of the application of FDA guidelines and ICH regulations from early development through commercial product
- Hands-on, roll-up-your-sleeves approach, with sense of urgency and motivation 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