MST, Manager Job Listing at Kelly Services in Columbus, MO (Job ID 9611295)

Description

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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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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