Buffer Manufacturing Team Lead - 2nd Shift

Merck•Saint Louis, MO

11d•Onsite

About The Position

The Buffer Manufacturing Team Lead at the Cherokee site plays a key role within the GMP Operations Systems & Support (OSS) team. This position is responsible for overseeing and guiding Manufacturing Scientists and Technicians in the preparation and manufacturing of buffers and solutions. The role requires a proactive approach to identifying and resolving issues while fostering a positive and collaborative work environment. This role does not offer sponsorship for work authorization, and external applicants must be eligible to work in the US.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other scientific discipline AND 2+ years of experience in GMP manufacturing or operations, in a pharmaceutical or biotechnology environment.
OR High School Diploma or GED AND 4+ years’ experience of experience in GMP manufacturing, in a pharmaceutical or biotechnology environment.
Personal protective equipment such as a respirator or chemical protective clothing for extended periods.

Nice To Haves

Excellent problem-solving abilities and a proactive approach to identifying and resolving issues, both process and mechanical.
Knowledge of process techniques, unit operations, and safe chemical handling methods.
Familiarity with regulatory requirements and industry best practices related to GMP manufacturing, including ICH regulatory and Quality standards.
Proficient in SAP, Microsoft Office and other software applications.
Strong leadership and interpersonal skills, with the ability to motivate and guide a diverse team.
Knowledge of Lean Manufacturing principles and continuous improvement methodologies (OpEx).

Responsibilities

Lead the buffer formulation team in the execution of cGMP buffer manufacturing.
Evaluate products according to established protocols, provide technical support to others, and perform operations in support of the group and department.
Safely perform operations to meet quality expectations.
Maintain required training to perform tasks/assignments.
Perform routine processes and unit operations.
Clean equipment and working areas during and after operations.
Support facility functions (e.g., maintain equipment, prepare reagents, restock supplies, waste disposal).
Revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines.
Communicate the status of operations and convey concerns to the supervisor.
Provide complete and accurate records consistent with quality guidelines.
Ensure all applicable logbooks are completed as required by current procedures.
Work cross-functionally with Project Management, Technical Operations, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
Help with MMF review.
Participate as needed in quality audits and customer interactions.
Improve processes by applying scientific knowledge, experience, and principles, in compliance with change control.
Take action to resolve unsafe conditions.
Train team members and act as technical consultants.