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Manager Bioprocess Engineer Jobs in Alabama (NOW HIRING)

We are looking to fill a Principal Engineer position working as a full-time employee of Parexel FSP ... Material Release Management:Actively support the timely release of raw materials and culture media ...

Manager Bioprocess Engineer information

What is the difference between Manager Bioprocess Engineer vs Process Development Scientist?

AspectManager Bioprocess EngineerProcess Development Scientist
CredentialsBachelor's/Master's in Bioengineering, Bioprocessing, or related; often requires experience in bioprocessingBachelor's/Master's in Biotechnology, Chemical Engineering, or related; research-focused background
Work EnvironmentManufacturing facilities, production lines, team managementResearch labs, development settings, experimental design
Industry UsageBiopharmaceutical manufacturing, biotech companiesResearch institutions, biotech R&D departments

The Manager Bioprocess Engineer oversees bioprocessing operations, ensuring production efficiency and compliance, while the Process Development Scientist focuses on developing and optimizing bioprocesses in research settings. Both roles require strong technical skills, but the manager role emphasizes leadership and manufacturing experience, whereas the scientist role centers on research and process innovation.

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Full-time

Re-posted 21 days ago


Job description

Company Description
A fully integrated biopharmaceutical company focused on developing a portfolio of innovative treatments for cancer and infectious diseases using their DNA-mediated gene transfer technologies.
Job Description
Company is seeking to hire a Bioprocess Engineer to support the company's ongoing development of novel immunotherapies. The position will play an integral role in the establishment of a GMP manufacturing facility to produce plasmid DNA active pharmaceutical ingredient (API).
• Lead the development of pilot scale downstream processing (DSP) unit operations of plasmid DNA from bacterial cell paste (from 10 L - 100 L bioreactor fermentation), to include lysis, clarification, ultrafiltration/diafiltration, and ion exchange chromatography.
• Plan and execute structured process development experiments to achieve the target yield, process optimization, product quality, scale-up and process robustness objectives.
• Play a pivotal role in the establishment of a GMP manufacturing facility to produce plasmid DNA active pharmaceutical ingredient (API).
• Document work thoroughly with a detail-oriented approach, write concise technical reports, and make effective presentations to management and other team members.
• Translate developed processes into standard operating procedures (SOPs) as well as necessary calibration and preventive maintenance SOPs.
• Write validation protocols and lead the technical support staff to successfully execute IQ, OQ, and PQ.
• Lead the process transition into the new facility.
• Troubleshoot, optimize, and improve ongoing process activity with scientific curiosity.
Qualifications
• B.S. or M.S. degree in Biochemical/Chemical Engineering preferred. Will also consider other disciplines such as biology, chemistry, or related field with requisite experience.
• 4+ years of hands-on biopharmaceutical experience at pilot or commercial scale with bioreactor fermentation (USP) and DSP of plasmid DNA from bacterial cell paste, including lysis, clarification, ultrafiltration/diafiltration, and ion exchange chromatography.
• 2+ years of experience working in a GMP manufacturing environment. Candidates with supervisory experience are preferred.
• Significant experience using ultrafiltration and diafiltration with tangential flow filtration (TFF) in a DSP unit operation.
Additional Information
Competitive salary, bonus, stock, relocation and benefits are offered.