Manufacturing Scientist

2 months ago

Oklahoma City, Oklahoma, United States Kelly Services, Inc. Full time
Job Title: Technical Advisor for Manufacturing

Location: Oklahoma City, OK (relocation assistance provided)

Salary: $110-120,000 + Benefits


Job Description:

The main responsibility of the Technical Advisor for Manufacturing is to support the manufacturing team as a technical advisor and operator. This role involves adapting 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.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.

Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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