MSAT Bioengineer – DSP

Boston Institute of Biotechnology; Mississippi; On-site; USD 60,000 - 80,000; Full time

Job description

As an MSAT Bioengineer – DSP, you are responsible for internal/external technology transfers and manufacturing support covering downstream purification processes (DSP) in BIB ’s lab and biologics manufacturing facilities. As a DSP Subject Matter Expert of global MSAT , you will provide advice and guidance on manufacturing technology issues, initiatives, and strategies for continuously improving manufacturing performance.

Responsibilities:

• As a MSAT Bioengineer – DSP, perform technology transfer activities among client, internal R&D/process development team, and GMP Manufacturing site focusing on downstream purification related processes.
• Perform Risk Assessment & Mitigation during product technology transfer and manufacturing.
• Support equipment IQ, OQ, PQ, deviation investigation, CAPA, and change control.
• Draft and review Manufacturing Process Description, Process Flow Diagram, Bill of Materials, Sampling Plan, Risk Assessment & Mitigation Plan, Data Trending and Statistical Analysis, and Process Performance Qualification/Process Validation Protocols.
• Review GMP or non-GMP documents including SOPs, batch records, production reports, and other related documents to fulfill CMC requirements.
• Maintain all notebooks and documentation according to department standards.
• Work well in a team environment and independently as required.
• Ensure and promote safe environmental and laboratory practices.

Qualifications:

• MS/BS degrees in Chemical Engineering, Biochemical Engineering, Bioengineering or related fields.
• MS with 3+ years or BS with 5+ years of hands-on experience in bioprocess related working environment.
• In depth understanding and hands-on experience on chromatography, depth filtration, nanofiltration, tangential flow filtration, scale up, and other related unit operations.
• Familiar with process simulation software such as SuperPro or Aspen Plus.
• Excellent troubleshooting and communication skills.
• Demonstrating ability to solve practical problems.
• Proven ability to work independently and on cross-functional teams

Please email your resume and why you believe you are a good fit for this position directly to [e-mail] Thank you!

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BIB is a full service CDMO partner offering cGMP and non-GMP mammalian, microbial, gene therapy and cell therapy services.