• 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
• 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
• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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

$94,300.00 - $148,500.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

No relocation