Sr. Spclst, Engineering

MSD

13d•Hybrid

About The Position

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.

Requirements

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.
Demonstrated technical expertise in bioreactor operations and upstream bioprocessing.
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.
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

Nice To Haves

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.

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 training 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.