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 Drug Product Fill/Finish Engineer to drive our drug product fill/finish 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, 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:
- Manage drug product fill/finish activities and lead technology transfer of drug product manufacturing processes to clinical and commercial manufacturing sites.
- Oversee activities drug product contract manufacturing organizations (CDMOs), including process development, media fills, pilot and engineering runs, cGMP production, in-process and release testing and stability activities.
- Review and approve Master Batch Records, Executed Batch Records, protocols, reports, method qualification documents, and stability documents.
- Author regulatory and technical documents for regulatory submissions in support of drug product manufacturing and formulation development.
- Utilize technical expertise to troubleshoot manufacturing process issues.
- Work closely with Quality, providing technical expertise to resolve CMO deviations and drive investigations to successful resolution.
- At times, work as “person-in-plant” to oversee routine and critical manufacturing operations at CDMOs as needed.
- Manage outsourced formulation development on drug substance and drug product in support of early-stage candidates
- Support CDMO and internal development of methods to support drug substance and drug product fill/finish at various clinical stages as per ICH guidelines.
- Serve as drug product fill/finish and formulation lead in multidisciplinary project teams and/or sub-team meetings within the company or with CDMO’s.
- Demonstrate innovative design, development and execution of drug product fill/finish and formulation projects through literature review and scientific teamwork.
- PhD (Chemical engineering, Bioengineering, Biology, Biochemistry or related field) with 2+ years’ experience, MS with 5+ years’ experience, or BS with 10+ years’ experience in drug product fill/finish and formulation development/QC of biologic products.
- Strong understanding of cGMPs, USP/Ph. Eur. and ICH guidelines and industry best practices for drug product fill/finish, including facilities and equipment set up and changeover.
- Strong background in drug product fill/finish life cycle, including scale up from Ph1 clinical to Ph2/commercial, and associated filling equipment.
- Proven ability to work independently and cooperatively in a team-based environment in designing and developing experiments, analyzing and interpreting data in a rigorous way.
- Ability to prioritize in a fast-paced environment, multi-task, and support multiple projects simultaneously.
- Strong organizational skills, analytical, problem-solving, and technical writing skills.
- Understanding and knowledge of key scientific software programs.
- Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives.
- Strong communication skills both written and oral with demonstrated ability to present ideas, information, and data effectively via one-on-one discussions, team meetings, teleconferences and partnership interactions.
- This role does not require individual to hands-on work in a laboratory performing formulation and fill/finish, instead supporting a European manufacturing network, including site visits.
- In addition to drug product fill/finish and formulation skill sets, German language proficiency and/or analytical development/qualification experience (working knowledge of in-process and release method analytical technologies for biologics, such as HPLC (various modes and detections), PCR, CE-SDS, cIEF, ELISA, LC-MS, DSC, FT-IR, CD, particle analysis, and potency assays) is a plus but not a requirement.
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 email@example.com.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.