Job Description

POSITION OVERVIEW

We are seeking a dedicated and experienced Manufacturing Manager to join our exciting and

growing team. This role is essential in ensuring proper manufacturing policies and procedures by

monitoring and reviewing operations, documents, and batch records. The ideal candidate in this

position is well organized, can solve problems, and work interpersonally with others. The

Manufacturing Manager will be responsible for batch record review, revising and reviewing

documents, coordinating manufacturing activities, managing the manufacturing schedule, and

being responsible for their direct reports. The manager must be glove and gown qualified to

provide management on the floor in case of conflicts. In addition, this role requires cross-

departmental collaboration.

 

Essential Duties and Responsibilities

· Responsible for batch record review.

· Revising and reviewing SOPs, OJTs, MPRs protocols, and other documents.

· Coordinate manufacturing activities with Manufacturing, Supply Chain, Quality

Assurance, Quality Control, and Patient Operations.

· Manage manufacturing schedule on Binocs.

· Must be glove & gown qualified to provide management on the floor during adverse

events.

· Responsible for direct reports which include but are not limited to ensuring timely

completion of training, scheduling, conducting performance reviews, reviewing and

approving timecards in a timely manner, etc.

· Monitor operations to ensure proper manufacturing policies and procedures.

· Additional duties and responsibilities as assigned.

Qualifications

· Bachelor’s degree in biology, chemistry, engineering, or related field.

· Must have at least 3 – 5 years of cGMP experience or relevant experience.

· Must have professional management experience, preferably in the biopharmaceutical

industry.

· Must have excellent communication skills both oral and written, interpersonal skills, and

organizational skills.

Physical Demands

· Prolonged periods sitting at a desk and working on a computer.
· Must be able to lift and/or move up to 30 pounds at times.
· May be required to bend, stoop, stretch, and stand for a prolonged period.

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