Job DescriptionThe MS&T department is seeking a
Process Engineer - Drug Product to support the Precigen, Inc. Drug Product Fill Finish activities that occur at a 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), at CMOs.
- Responsible for onsite Person in Plant activities at CMO locations DP Fill Finish.
- 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.
- Collect and trend process data, perform process capability assessments, and identify areas for continuous improvement related to DP Fill Finish.
- 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.
- 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.
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.
DESIRED KEY COMPETENCIES:- Strong technical and scientific knowledge of drug product manufacturing operations.
- Experience with manufacture of viral vectors and/or viral vaccines is a plus
- Critical thinking and strong problem-solving skills with quantitative and analytical mind-set.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Perform other responsibilities to support the needs of the department, as assigned.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Experience with JMP statistical software
- Knowledge and experience in Operational Excellence (OE) methodologies is a plus.
- Maintains a high degree of ethical standard and trustworthiness.
- Exhibits and open mindset when approaching challenges and conflict.
- Demonstrates the ability to mentor and coach team members in all areas of expertise.
- Working conditions and physical requirements:
- Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies.
- May need to work with hazardous materials.
- Able to stand up to 4 hours at a time.
