Process Engineer - Drug Product

Precigen, Inc•Germantown, MD

27d

About The Position

Precigen is a dedicated commercial and clinical stage biopharmaceutical company advancing the next generation of gene 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. The 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.

Requirements

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 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.
Strong technical and scientific knowledge of drug product manufacturing operations.
Critical thinking and strong problem-solving skills with quantitative and analytical mind-set.
Self-organizer, meticulous hands-on habits, keen attention to detail.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Maintains a high degree of ethical standard and trustworthiness.
Exhibits and open mindset when approaching challenges and conflict.

Nice To Haves

Experience in process development and/or process scale-up studies of Drug Product Fill Finish operations is a plus.
Experience with manufacture of viral vectors and/or viral vaccines is a plus
Experience with JMP statistical software
Knowledge and experience in Operational Excellence (OE) methodologies is a plus.
Demonstrates the ability to mentor and coach team members in all areas of expertise.

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.
Perform other responsibilities to support the needs of the department, as assigned.