Manager, MST

6 days ago

Oklahoma City, United States Kelly Science, Engineering, Technology & Telecom Full time

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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