Sr. Spclst, Engineering

Senior Specialist, Gmp Process Operations

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Senior Specialist, Gmp Process Operations, serves as a technical expert and operational leader within the upstream bioreactor operations team. This role is hands-on, providing both direct process execution and leadership across multiple manufacturing campaigns. The Senior Specialist applies deep technical knowledge of bioreactor systems and Gmp compliance to ensure successful production of clinical materials, effective technology transfer of new processes and continuous improvement of manufacturing operations.

Key Responsibilities:

• Lead and execute Gmp bioreactor operations across multiple scales ranging from benchtop to 2000L in stainless steel, glass, and single-use systems.
• Direct and coordinate upstream campaign teams ensuring safety compliance and schedule adherence.
• Serve as a subject matter expert for bioreactor operations, including system design, process control, and troubleshooting.
• Provide technical leadership in deviation investigations, CapA implementation, and change control activities.
• Partner with process development, engineering, and quality to introduce, scale, and optimize new processes in the Gmp manufacturing environment.
• Drive continuous improvement initiatives related to process robustness, equipment reliability, and operational efficiency.
• Mentor and train Specialists and Associate Specialists in technical execution, Gmp documentation, and problem-solving methodologies.
• Maintain accurate and compliant documentation including batch records, logbooks, and deviation reports.
• Promote a strong safety and quality culture through example and engagement.

Education:

• Bachelor’s degree in biology, biotechnology, chemical engineering, or related field with 5 or more years of relevant experience, or
• Master’s degree with 3 or more years of relevant experience.

Experience:

• Required: Demonstrated technical expertise in bioreactor operations and upstream bioprocessing.
• Preferred: Proven experience leading manufacturing teams in a Gmp environment.
• Proficiency with DeltaV and/or Unicorn control systems preferred.
• Experience supporting or owning deviations, CapAs, and change controls.
• Strong working knowledge of Gmp documentation and regulatory expectations for clinical manufacturing.

Key Attributes:

• Recognized as a technical leader with strong analytical and troubleshooting skills.
• Demonstrated ability to lead teams and foster collaboration across functions.
• High degree of ownership, accountability, and professional integrity.
• Effective communicator capable of translating complex technical concepts to diverse audiences.
• Flexible and adaptable to dynamic clinical production environments including off-shift work as required.

Required Skills:

• Adaptability, Analytical Testing, Biomanufacturing, Biotechnology, Chemical Biology, Chemical Engineering, Chemical Technology, Continuous Process Improvement, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Gmp Compliance, Good Manufacturing Practices (Gmp), Immunochemistry, Process Design, Process Hazard Analysis (PhA), Process Optimization, Root Cause Analysis (Rca), Safety Compliance, Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

The salary range for this role is $114,700.00 - $180,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.