MST, Manager
Oklahoma City, OK

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.
Job Responsibilities:

• Practice and promote safe work practices and adhere to safety procedures and guidelines.
  

• 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
      

    
    

• Provide support to cross-functional teams to meet production or timeline demands.
  

• Represent the MSAT to clients and on cross-functional project teams.
  

• Train new staff in scientific concepts, technical operations, safety, and Good Manufacturing Practices.
  

• Collaborate with vendors, and stay up to date on Biotech industry trends, progress, and standards.
  

• Participate in program meetings independently
  

• Review contract proposals and provide feedback pertaining to facility fit.
  

• Independently manage process transfer to late phase/commercial stage.
  

• Participate in FMEA analysis and PV documentation.
  

• Ensure batches adhere to established Quality standards.
  

• Engage in continuous improvement initiatives with production managers.
  

• Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues and improve process operations.

Job 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.

Job Details:

• Direct Hire!
  

• Full benefits package
  

• Competitive Salary
  

• M-F; 8am-5pm/flexible to work extended hours

9611295