Senior Specialist, Operations (Fermentation)

Job Description

Join our Manufacturing Operations team as a Sr. Operations Specialist (Fermentation) in Desoto, Kansas! The Sr. Specialist will serve as both Project Lead and system/sub-system owner for key functions supporting manufacturing operations in critical GMP, compliance, and operational improvement activities. You will serve as  a pivotal Change Manager and Stakeholder for change management activities at the De Soto site and support team development and mentorship.

 This role is ideal for candidates with a “Safety First, Quality Always” mindset, passionate about creating a culture of continuous improvement and leading by example. You will own the execution of effective problem solving within Operations and ensure that outcomes are shared appropriately with cross-functional teams.

Primary Responsibilities Includes:

Process Leadership:

• Design, monitor, and optimize fermentation processes for maximum yield and product quality.
• Scale up fermentation from laboratory to pilot and full production levels.
• Analyze microbial growth conditions and maintain sterile environments.
• Troubleshoot and resolve technical issues during fermentation, including equipment and process deviations.

Safety Compliance:

• Demonstrates a strong compliance mindset (EHS, Quality, and Finance) and continuously sets a high standard for themselves and their team. 
• Responsible for safety event management and root cause investigation.

Quality Compliance:

• Accountable for the on-time completion of Quality compliance tasks in relation to Deviation, CAPA, Change Control Management, and Project Management.
• Accountable for all aspects of Quality Assurance including cGMP, RFT, and good documentation practices and provides coaching to the Operations teams.
• Accountable for the update, review, and approval of GMP documentation required in relation to assigned projects, including, but not limited to:
  • Standard Operating Procedure
  • Manufacturing Directions
  • Qualification Protocols
  • New product/product transfer documentation

Productivity:

• SAP Key User and Subject Matter Expert (SME).
• Accountable for the execution of effective problem solving within Operations and ensures that outcomes are shared appropriately.
• Recognizes and investigates opportunities for financial savings.

Employee Development

• Acts as a Subject Matter Expert (SME) to support coaching and skills development within the Operations.
• Acts as a Subject Matter Expert (SME) for the delivery of training material specific to their assigned responsibilities.

Required Experience and Skills:

• Bachelors in a relevant scientific discipline.

• Minimum of 5 years of experience in Fermentation and/ or Aseptic Processing in Manufacturing Operations.
• Experience working in a GMP manufacturing environment.
• Experience with one or more of the following technologies/processes: Bacterial fermentation, Tangential Flow Filtration or Chromatography,
• Experience with safety event management and root cause investigation
• Understanding of aseptic processes used in manufacturing.
• Experience using quality improvement tools and continuous improvement processes and site quality metrics.

Required Skills:

Analytical Problem Solving, Aseptic Processing, cGMP Compliance, Change Management, Critical Thinking, Fermentation Process Development, Fermentations, GMP Compliance, Manufacturing Operations, Problem Solving, Process Leadership, Quality Compliance, Safety Compliance, Sterile Operations

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability s