GMP Associate Production Scientist - Rotating Shift

Merck•Saint Louis, MO

1d•Onsite

About The Position

Join MilliporeSigma’s St. Louis Cherokee facility, a contract development and manufacturing organization and Center of Excellence for antibody-drug conjugate (ADC) manufacturing. The Associate Production Scientist manufactures products according to established protocols under ICH Q7 pharmaceutical regulations, provides technical support, and performs operations in support of the group and department. The role works 12-hour rotating day and night shifts, with a 20% shift differential, and is expected to spend approximately 70% of the time on the production floor. The position does not offer work authorization sponsorship; external applicants must be eligible to work in the United States.

Requirements

Bachelor’s degree in a scientific discipline such as Chemistry, Biochemistry, or Biology, or an associate degree in Chemistry, Biochemistry, Biology, or another life science discipline.
At least 2 years of industry production or laboratory experience.
Ability to lift up to 50 pounds.
Ability to wear personal protective equipment, such as a respirator or chemical protective clothing, for extended periods.

Nice To Haves

Experience with antibody-drug conjugates (ADCs), including knowledge of formulation and manufacturing processes.
Experience with automated tangential flow and automated chromatography systems.
Familiarity with laboratory instruments and production equipment.
Familiarity with process techniques, unit operations, and safe chemical-handling methods.
Experience with Microsoft Office, including Word, Outlook, and Excel.
Mechanical and troubleshooting skills.
Knowledge of cGMP and ICH regulatory and quality standards.
Knowledge of Operational Excellence.
Cleanroom experience.
Ability to interact professionally in customer-facing meetings, including challenging discussions about process planning and execution.

Responsibilities

Evaluate products using established protocols, provide technical support, and perform operations to meet departmental goals.
Safely conduct routine processes and unit operations, including cleaning equipment and work areas, while meeting quality expectations.
Maintain required training and qualifications, train team members, and act as a technical consultant.
Support facility functions by maintaining equipment, preparing reagents, restocking supplies, and managing waste disposal.
Maintain accurate records and logbooks according to quality guidelines and communicate operational status and concerns to supervision.
Collaborate with other departments, participate in quality audits and customer interactions, and perform procedures independently or as part of a team.
Improve processes using scientific knowledge and principles while ensuring compliance with change control.
Promptly address unsafe conditions and troubleshoot challenges related to biological processes and GMP compliance.