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Merck · 4 days ago

Senior Specialist, Operations (Fermentation)

De Soto, KS

Full-time

Hybrid

Mid, Senior Level

$94K/yr - $148K/yr

5+ years exp

Merck is seeking a Senior Specialist in Operations to join their Manufacturing Operations team in De Soto, Kansas. The role involves leading fermentation process optimization, ensuring compliance with safety and quality standards, and mentoring team members.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Fermentation Process DevelopmentCGMP ComplianceAseptic ProcessingChange ManagementAnalytical Problem SolvingQuality ComplianceSafety ComplianceManufacturing OperationsProcess LeadershipSterile OperationsCritical ThinkingProblem Solving