Senior Engineer, CMC (Upstream Manufacturing and Process Development)
Pionyr Immunotherapeutics, Inc., an expanding, well-funded South San Francisco-based clinical stage immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced and motivated Upstream Process Engineer to help drive our drug substance activities in partnership with our Technical Operations team and external CDMO partners. The successful candidate will play a key role in supporting our clinical development activities, with two clinical trials in progress, with products moving toward Ph2/commercial development, as well as our expanding new product pipeline, with CDMO locations in Berlin and Heidelberg, Germany, and Basel, Stein, and Visp, Switzerland. Come be a Pionyr!
Responsibilities include but not limited to:
- Oversee cGMP manufacturing, process development, scale-up, and technology transfer of upstream processes at contract manufacturing organizations (CDMOs)
- Ensure development of robust, scalable upstream processes at CDMOs for production of clinical material based on QbD principles.
- Guide development activities including cell line development, clone selection, cryopreservation, small scale model development/qualification, scale-up (1-2000 L), process characterization, and validation.
- Assure cGMP compliant cell line development, cell banking, manufacturing, and material supply for production of research, toxicology and clinical materials to meet project timelines.
- Leverage strong understanding of mammalian cell culture to troubleshoot manufacturing and process development issues
- Work closely with Quality, providing technical expertise to resolve CMO deviations and drive investigations to successful resolution.
- Lead upstream process transfer from and to CDMOs
- Review and approve Master and Executed Batch Records, protocols, reports, transfer documents, and process descriptions.
- Lead from the desk (designing studies, analyzing data, reviewing and authoring reports, documents, and regulatory filings), with prior experience from the bench (hands-on laboratory work).
- Provide leadership and influence as a primary contact with various CDMO.
- Author CMC regulatory and technical documents for regulatory submissions.
- Maintains a current awareness and contributes to current scientific literature; actively applies new concepts and technologies as appropriate.
- Observes and complies with Company’s and CDMO’s Safety policies and procedures.
- PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Immunology, Virology, or related field) with 2+ year experience, MS with 5+ year experience, or BS with 10+ year experience in process development of biologics or cellular therapies with background in protein engineering preferred.
- Knowledge and working experience of upstream (cell culture) process development in mammalian cells, including (flask, ambr, DASBOX, DASGIP, single use bioreactors, and scale up (1-2000 L), media development/optimization, process scale-up, bioreactor design, harvest, and Good Manufacturing Practices (GMP).
- Experience in technology transfer is essential. Expertise in process characterization, validation, DOE and statistical analysis of data is highly desirable, as is experience in process troubleshooting, deviation management, and root cause analysis.
- Proven ability to work independently and support others in designing and executing experiments, processes, analyzing and interpreting data, and troubleshooting.
- Ability to work in a team-based environment cooperatively and supportive of multiple viewpoints and approaches.
- Ability to assess and triage risk, negotiate and influence, and lead CDMO as primary liaison without direct authority to drive for best development path forward and successful commercialization.
- Ability to prioritize in a fast-paced environment, multi-task, and support more than one project simultaneously.
- Understanding and knowledge of US/EU regulatory requirements for biologic products (CFR, Eudralex, and ICH guidelines), and experience in authoring CMC sections of IND filings.
- Strong organizational skills, analytical and problem-solving skills.
- Strong communication skills, both written and oral, with demonstrated ability to present ideas, information, and data effectively via one on one discussions, team meetings, and teleconferences.
- Technical SME across multiple aspects of industrial mAb platform preferred, including product and process development, upstream cell culture, downstream purification, technology transfer, formulation, validation, manufacturing, and quality.
- Internal/external analytical assay development/qualification experience, including in-process and drug substance/drug product release, is a plus but not required.
- In addition to upstream, knowledge and working experience of downstream (purification) process development in mammalian cells aligned with the industrial mAb platform, including Protein A affinity chromatography, low pH viral inactivation, depth filtration, anion exchange and cation exchange chromatography, nanofiltration, UF/DF, formulation, and Good Manufacturing Practices (GMP) is a plus but not required.
- Ability to travel domestically and internationally 15%.
How to Apply
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to firstname.lastname@example.org.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.