Senior Manager, Quality
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 Sr. Manager, Quality.
Reporting to the VP, Quality, this pivotal role will focus on quality support and oversight of technology transfer activities. The successful candidate will play a key role in supporting our clinical development activities, with two clinical trials in progress, products moving toward Ph2/commercial development, as well as our expanding new product pipeline. This role will also interact and partner with our CDMOs located 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:
- Provide quality oversight to technology transfer, cGMP manufacturing, process development, and scale-up at contract manufacturing organizations (CDMOs)
- Assure cGMP compliant manufacturing, and material supply for production of clinical and toxicology materials to meet project timelines
- Review and approve Master and Executed Batch Records, protocols, reports, transfer documents, and process descriptions
- Work closely with Pionyr Technical Operations to evaluate major/critical deviations; influence CDMOs and advocate for high quality standards, ensuring successful resolution
- Release lots, including Drug Substance, Drug Product, and Finished Goods in partnership with CDMO Quality, CDMO QP and Pionyr QP
- Participate in Change Control, CAPA, and Quality Events/Deviation assessment and execution
- Support Pionyr Compliance Audit program, participate in remote and on-site audits
- Support definition and realization of Pionyr GMP roadmap, building and implementing phase-appropriate quality processes
- Support quality oversight to clinical distribution/clinical depots
- May support clinical quality activities, as needed
- Stay current on GxP compliance standards, regulations, and guidelines; actively apply new standards in risk-based and phase-appropriate manner
- BS or higher degree in relevant technical field; MS with a minimum of 3+ years’ experience, or BS with a minimum of 5+ years’ experience in biotech/pharmaceutical industry
- External quality experience
- Experience in biologics manufacturing
- Experience with technology transfer
- Expert knowledge of US/EU regulatory requirements for biologic products
- Proven ability to make fact-based quality decisions using risk management principles
- Strong organizational skills, with ability to be change agile, and support multiple projects simultaneously
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.