Job Description
Job Description Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen has developed novel manufacturing processes to deliver UltraCAR-T and AdenoVerse immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.
We are seeking a
Process Engineer – DP Fill Finish/Packaging to support the Precigen, Inc. Drug Product Fill Finish and Packaging activities that occur at CMO. This position will require a professional who is technically savvy, thrives in a dynamic team environment, poses exceptional problem-solving skills, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will be supporting all technical aspects of Gene Therapy cGMP manufacturing of late clinical stage to commercialization of Adenovector products, including process transfer, process validation, continuous process verification, person in plant manufacturing support, and regulatory filings.
DUTIES AND RESPONSIBILITIES: - Responsible for end-to-end technical support of gene therapy product manufacturing (Drug Product Fill Finish/Packaging), at CMOs.
- Responsible for onsite Person in Plant activities at CMO locations DP Fill Finish/Packaging.
- Works cross functionally with Process Development, CMO, Quality Assurance, Quality Control, Supply Chain, and Validation departments to effectively transfer, implement and maintain processes at multiple facilities.
- Works closely with the CMO to provide on-the-floor technical oversight through each product campaign startup as well as in response to any process/equipment troubleshooting requirements related to DP Fill Finish/Packaging.
- Collect and trend process data, perform process capability assessments, and identify areas for continuous improvement related to DP Fill Finish/Packaging.
- Authors and/or reviews technical reports, process tech transfer summary reports, risk assessments, master batch records, equipment user requirement specifications, and protocols in support of tech transfer, cGMP activities and regulatory filings.
- Provide technical support for investigations and lend expertise in problem solving activities on existing production activities, determining root cause and corrective actions.
- Lead / support process improvement projects, including new technologies for DP Fill Finish/Packaging.
- Offer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions, and Validation protocols at CMO for DP Fill Finish/Packaging.
EDUCATION AND EXPERIENCE :
- B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology or another relevant engineering / scientific qualification. Level will be determined based on education and experience.
- 3-4 years of experience in a biopharmaceutical manufacturing setting where the individual has implemented process changes/optimization, technology transfer, and manufacturing support.
- Experience in process development and/or process scale-up studies of Drug Product Fill Finish operations is a plus.
- Experience summarizing and presenting data, statistical analysis, and authoring technical reports.
- Strong computer skills with Microsoft Office, data trending/management software (Excel and Jmp) and the ability to quickly learn new applications.
EOE
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