Senior Specialist, Operations (Fermentation)

Merck•De Soto, KS

15h•Hybrid

About The Position

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.

Requirements

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.
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

Responsibilities

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.
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.
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
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.
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.