Manager/Senior Manager, Manufacturing Science and Technology
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Job Detail
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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 an experienced Manager/Senior Manager, Manufacturing Science and Technology (MS&T) at our Germantown, MD location to join us in our mission to serve patients with our next generation of innovative Gene Therapies.  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, manufacturing support, and regulatory filings.
DUTIES AND RESPONSIBILITIES:
- Responsible for end-to-end technical support of gene therapy product manufacturing (drug substance and drug product), in-house and at CMOs.
- Works cross functionally with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments to effectively transfer, implement and maintain processes in multiple facilities.
- Works closely with manufacturing to provide on-the-floor technical oversight through each product campaign startup as well as in response to any process/equipment troubleshooting requirements, including at CMOs.
- Collect and trend process data, perform process capability assessments, and identify areas for continues improvement.
- Authors and/or reviews technical reports, process tech transfer summary reports, risk assessments, master batch records, product and equipment 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.
- Offer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions, and Validation protocols.
- Develop and serve as a center of excellence for manufacturing data management and operational improvement.
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.
- 4+ years of experience in management of activities required for successful implementation of process changes/optimization, technology transfer, and manufacturing support in late stage clinical and/or commercial cGMP biopharmaceutical manufacturing operation is required.
- Hands-on laboratory experience in process development and/or process scale-up studies of upstream cell culture (CHO, NS0, HEK 293, or other) and downstream unit operations (bioreactors, incubators, centrifugation/filtration, and chromatography systems) as well as 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, MiniTab, BioSolve) and the ability to quickly learn new applications.
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DESIRED KEY COMPETENCIES:
- Strong technical and scientific knowledge of upstream and downstream vaccine/vector manufacturing unit operations, including fill/finish.
- Experience with manufacture of viral vectors and/or viral vaccines is a plus
- Excellent technical writing skills.
- 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 SAS/JMP statistical software and BioSolve is a plus.
- Knowledge and experience in Operational Excellence (OE) methodologies is a plus.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits and open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- 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.