Manager, MST
1 month ago
Job Title: Manager, MST
Location: Oklahoma City, OK (relocation assistance provided)
Shift: Mon-Fri | 8am-5pm (flexible)
The primary responsibility of the Manufacturing Science Technology (MST), Manager is to support the manufacturing team as a Technology transfer leader and technical advisor for biotechnology company. Manufacturing scientist adapt processes demonstrated at the R&D scale to final manufacturing scale. Secondary roles include driving/contributing to continual improvement initiatives and providing input to production scheduling.
RESPONSIBILITIES:
- Demonstrate a thorough understanding of current Good Manufacturing Practices, adhere to Quality standards, and learn and comply with regulatory requirements.
- Exhibit proficiency in understanding concepts and scale-up requirements for all departmental disciplines with limited supervision required (listed below).
- Mammalian cell culture (suspension and adherent)
- Microbial cell culture (bacterial and yeast)
- Downstream Purification
- Gene Therapy (pDNA and AAV)- preferred
Transfer the process to Manufacturing. This includes but is not limited to:
- Adapting processes to manufacturing large scale with limited supervision.
- Provide suggestions for process optimization and efficiency, where applicable.
- Perform Facility Fit analysis and work in conjunction with the engineering group to source new production equipment.
- Ordering appropriate raw materials for the manufacturing process.
Authoring, reviewing, and approving technical documentation including but not limited to:
- R&D Process Descriptions
- Tech transfer document
- Batch records / Protocols
- Summary reports
Provide support during ongoing manufacturing campaigns by:
- Performing data trending analysis
- Troubleshooting issues with the ability to interpret process trends and data and react appropriately to unexpected outcomes
Interface with the Quality Assurance department to:
- Collaborate on Material Specifications
- Author Temporary Changes
- Author Risk Assessments
- Author/Review Change Requests
- Initiate investigation reports.
- Execute corrective actions / preventative actions
REQUIREMENTS:
- An advanced degree (M.S. or Ph.D.) in Chemical Engineering or life sciences required with laboratory experience.
- The ideal candidate will have 4 – 10 years of experience in MSAT and/or GMP production with >5 years of experience as a technical SME for manufacturing scale in similar role. Biologics production is required.
- Proven track record of supervising a group of 4+ employees in a biologics technical SME production environment (Process Engineering, Manufacturing Sciences & Technology) etc.
- Experience in early-phase, and late-phase technical transfer and scale-up required.
- Experience authoring GMP documentation required.
- Experience in FMEA and Root Cause analysis.
- Proficient technical writing skills required.
- Proficient verbal communication and presentation skills are required to translate general scientific and manufacturing concepts to a broad audience
- Experience with process validation and commercial manufacturing preferred.
- Experience with production OIT software a plus (e.g. Unicorn, SCADA, Delta V, RS Batch, Pi Historian).
- Must be highly motivated, and detail-oriented, follow oral and written instructions, communicate effectively, think logically, and thrive independently in a fast-paced team environment.
- Innovative, energetic, collaborative, quality-minded, detail-oriented, and dedicated to delivery on time.
- Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
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Manager, MST
1 month ago
Oklahoma City, United States Kelly Science, Engineering, Technology & Telecom Full timeJob Title: Manager, MST Location: Oklahoma City, OK (relocation assistance provided) Shift: Mon-Fri | 8am-5pm (flexible) The primary responsibility of the Manufacturing Science Technology (MST), Manager is to support the manufacturing team as a Technology transfer leader and technical advisor for biotechnology company. Manufacturing scientist adapt...
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del city, United States Kelly Science, Engineering, Technology & Telecom Full timeJob Title: Manager, MSTLocation: Oklahoma City, OK (relocation assistance provided)Shift: Mon-Fri | 8am-5pm (flexible)The primary responsibility of the Manufacturing Science Technology (MST), Manager is to support the manufacturing team as a Technology transfer leader and technical advisor for biotechnology company. Manufacturing scientist adapt processes...
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del city, United States Kelly Science, Engineering, Technology & Telecom Full timeJob Title: Manager, MSTLocation: Oklahoma City, OK (relocation assistance provided)Shift: Mon-Fri | 8am-5pm (flexible)The primary responsibility of the Manufacturing Science Technology (MST), Manager is to support the manufacturing team as a Technology transfer leader and technical advisor for biotechnology company. Manufacturing scientist adapt processes...
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