Engineer, CMC (Global Downstream 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 Downstream 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, Basel, Stein, and Visp, Switzerland Athlone, Ireland, Slough, UK, and Hayward, California. Come be a Pionyr!
Responsibilities include but not limited to:
- Guide cGMP manufacturing, process development, scale-up, and technology transfer of downstream processes at contract manufacturing organizations (CDMOs), including chromatography, depth filtration, viral filtration, and UF/DF steps, and cryopreservation, including small scale model development/qualification, scale-up, and process optimization/characterization.
- Ensure development of robust, scalable downstream processes at CDMOs for production of clinical materials based on QbD principles.
- Leverage strong understanding of DOE and statistical techniques to design, assess and interpret experimental data.
- Lead downstream process transfer from and to CDMOs.
- Assure cGMP compliant downstream manufacturing and material supply for production of research, toxicology and clinical materials to meet project timelines.
- Review and approve Master and Executed Batch Records, protocols, reports, transfer documents, and process descriptions.
- Support cGMP manufacturing as Person-in-Plant during clinical production.
- Work closely with Quality, providing technical expertise to resolve deviations and drive investigations to successful resolution.
- Lead from the desk (designing studies, analyzing data, reviewing and authoring reports, documents, regulatory filings, and troubleshooting)
- Provide leadership and influence as a primary contact with various CDMO.
- Author and review CMC regulatory and technical documents for regualtory 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), MS with 3+ year experience, or BS with 5+ year experience in process development of biologics or cellular therapies, with background in cell culture/protein engineering preferred
- Knowledge and hands-onexperience of upstream (cell culture) process development in mammalian cells, including expansion and production process design, media development/optimization, process scale-up, bioreactor design, harvest and Good Manufacturing Practices (GMP)
- Experience with process development and technology transfer is essential.
- Expertise in process characterization, validation, DOE and statistical analysis of data is 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.
- Strong organizational skills, with ability to be change agile, 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 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 discussion, team meetings, and teleconferences.
- 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 downstream, knowledge and working experience of upstream process development and scale-up of mammalian cell culture is a plus but not required.
- Ability to travel domestically and internationally 15%.
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.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.