- Seeking a driven individual with extensive downstream process development and manufacturing experience with biologics to be a valuable member of a growing 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 downstream process responsibilities including development, validation, and GMP manufacturing of monoclonal antibodies at premier external contract development and manufacturing organizations (CDMO).
- The candidate will cooperate with various internal functions such as: upstream manufacturing, regulatory, quality assurance, quality control and supply chain to ensure optimal practices are implemented and followed at external contract manufacturing and testing labs, as well as internally.
Specific responsibilities include:
- Manage entirety of downstream process development, validation, optimization and GMP manufacturing activities at a premier CDMO for clinical supply through launch/BLA -purification, formulation, and fill/finish.
- Co-author batch records, validation reports/protocols in cooperation with the CDMO
- Use creative problem-solving skills to independently troubleshoot experimental obstacles, analyze data, define problems, establish facts, draw defensible conclusions and make decisions.
- Assist with the trending of process development, validation, and manufacturing data for continuous improvement of processes.
- Manage of 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 external contract sites.
- Author relevant sections of IND/IMPD regulatory filings
Education / Experience / Skills:
- S., M.S. or Ph.D. in chemical engineering, bioengineering, biochemistry, or equivalent.
- 6-10+ years (depending on education) of progressive practical experience in process development and GMP manufacturing of monoclonal antibodies in the biotech/pharmaceuticals industry.
- Substantial experience with managing external contract partners is desired.
- Process validation experience in support of late-stage clinical programs is desired (DoE, IQ/OQ/PQ)
- Fill/Finish experience desired but not essential
- Extensive knowledge of the application of FDA and ICH regulations/guidelines from early-development through commercial products