Scientist II - Biologics Pilot Plant

Summary:
Merck's Biologics Pilot Plant at the West Point site manufactures cell banks, biologics, vaccines, and adjuvants for GMP clinical supply. The Process Operations Team is seeking a highly motivated Scientist II to develop, implement, and maintain an effective training program for GMP manufacturing operations.

This role will focus on preparing team members to safely and compliantly perform upstream and downstream manufacturing activities. The successful candidate will have hands-on GMP manufacturing experience, strong technical knowledge of biologics processing equipment, and a passion for teaching, training, and developing team members. Additional hands-on production support may also be required.

Responsibilities:

• Build, implement, and maintain the Operations Team training program.
• Develop and establish a training strategy that continually strengthens team capabilities and operator proficiency.
• Deliver and coordinate instructor-led training for upstream and downstream processing equipment to support GMP manufacturing campaigns.
• Design and implement interactive, hands-on training activities, including water runs and equipment mock-ups.
• Prepare team members to perform GMP processing activities safely, effectively, and in compliance with established procedures.
• Provide technical instruction and support for upstream and downstream unit operations.
• Evaluate training needs and support the ongoing development of manufacturing team members.
• Maintain an effective training approach that supports consistent execution of manufacturing processes.
• Provide hands-on production support for GMP upstream and downstream manufacturing operations, as needed.

Required Qualifications:

• Experience working in a GMP clinical or manufacturing facility.
• Experience with upstream unit operations involving suspension and/or adherent cell lines under aseptic conditions.
• Experience with downstream unit operations, including dead-end filtration, tangential flow filtration, and chromatography.
• Effective written and verbal communication skills.
• Strong interpersonal and collaboration skills.
• Demonstrated interest in teaching, training, and developing team members.

Preferred / Desired Technical Expertise:

• Incubators: Experience with static and shaker incubators.
• Cell Culture: Experience with suspension and adherent cell-culture flasks.
• Bioreactors: Single-use bioreactors, including Cytiva WAVE and Thermo Fisher HyPerforma systems.
• Stainless-steel bioreactors.

Analytical Equipment:

• Cell counters, including the Vi-CELL BLU.
• Metabolite analyzers, including the BioProfile FLEX2 and ABL90.
• Spectrophotometers, including the SoloVPE.
• Filtration: Experience with large-scale filter holders from Millipore, Pall, 3M, or similar manufacturers.

Chromatography and Purification:

• Cytiva ÄKTA ready chromatography systems.
• Cytiva ÄKTA flux tangential flow filtration systems.

Education:

• Required: Bachelors Degree

Additional Information:
Location: Merck Biologics Pilot Plant, West Point, PA.
Team: Process Operations.
Manufacturing Environment: GMP clinical supply manufacturing, supporting cell banks, biologics, vaccines, and adjuvants.
The primary focus of this position is developing and sustaining the Operations Team training program, with potential hands-on support of GMP manufacturing activities.