Job Title: Manufacturing Scientist
Location: Oklahoma City, OK (relocation assistance provided)
Salary: $110-120,000 + Benefits

Job Description:
The main responsibility of the Manufacturing Scientist is to support the manufacturing team as a technical advisor and operator. Manufacturing scientist adapt processes demonstrated at the R&D scale to the final manufacturing scale.  Secondary roles include driving/contributing to continual improvement initiatives and providing input to production scheduling. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

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

• Demonstrate understanding in Good Manufacturing Practice and 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)
    

  
  

• Transfer the process to Manufacturing.  This includes but is not limited to:
  

  • Adapting processes to manufacturing large scale with limited supervision required.
    

  • 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:
  

  • Perform 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
    

  
  

• Group Management duties:
  

  • Supervise Manufacturing Sciences personnel.
    

  • Coordinate with production supervisors, managers and PM’s to execute production campaigns on time.
    

  • Ensure batches adhere to established Quality standards. 
    

  • Conduct performance reviews of Manufacturing Sciences personnel.
    

  • Provide input for hiring new manufacturing scientists and conduct interviews. 
    

  • Provide input for future growth of the group and budgeting. 
    

  • 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.
    

  
  

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

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

• Train new staff in scientific concepts, technical operations, safety, and GMP.
  

• Collaborate with vendors, and stay up-to-date on industry news, progress, and standards.
  

• Participate in program meetings without supervision required
  

• Review contract proposals and provide feedback pertaining to facility fit
  

• Participate in Failure Mode Effects Analysis (FMEA)

JOB REQUIREMENTS:

• B.S. in life science or related degree required with laboratory experience preferred.
  

• The ideal candidate will have 4 – 10 years of experience in GMP production or an advanced degree (MS or PhD) with 2 – 5 years of experience in GMP production.  
  

• Must have >4 years of experience as a technical SME for manufacturing scale in a similar role.  Biologics production is required.
  

• Proven track record of supervising a group of 4+ employees in a biologics technical SME production environment (Manufacturing Sciences, Manufacturing Sciences and Technology, Process Engineering, etc) required.
  

• Experience in early-phase and late-phase technical transfer and scale-up required.
  

• Experience authoring GMP documentation required. 
  

• Proficient technical writing skills required.
  

• Proficient public speaking skills are required to translate general scientific and manufacturing concepts to a broad audience
  

• Experience with production OIT software a plus (e.g. Unicorn, SCADA, Delta V, RS Batch, Pi Historian).
  

• Must be proficient in Word and Excel.
  

• Must be highly motivated, 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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