Associate Manager, Production

American Regent, Inc.•New Albany, OH

12d

About The Position

The Associate Manager, Production is a senior member of the Manufacturing Team, which manufactures safe, effective, sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. This role ensures required aseptic and sanitary conditions are maintained, manufacturing area and equipment records are accurate, and professional and safe conduct is observed. The Associate Manager supports other departments as needed and helps maintain production schedules and meet company goals. The role oversees the manufacturing process, including component preparation, aseptic cleaning, compounding, filtration, and filling, in accordance with established production records. The Associate Manager may perform, oversee, and approve manufacturing activities; provide direction, training, and mentorship to less-experienced supervisors; and ensure proper use of batch documentation. The position also troubleshoots manufacturing processes and equipment and may make adjustments or minor repairs during setup and operations.

Requirements

High school diploma or GED equivalent.
At least 1 year of leadership experience in a manufacturing industry subject to GMP/FDA regulations.
Excellent chemical-handling and mathematical aptitude.
Ability to assemble and troubleshoot manufacturing equipment and perform minor repairs.
Experience writing, reviewing, and executing standard operating procedures.
Ability to read Standard English documents, including standard operating procedures, maintenance schedules, and operating manuals.
Ability to wear cleanroom and protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
Must maintain a clean-shaven appearance each working shift to properly wear tight-fitting respirators.
Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

Bachelor’s degree in Pharmaceutical Science, Chemistry, (Micro) Biology, Engineering, or a related field.
At least 5 years of experience in the sterile pharmaceutical manufacturing industry.
Knowledge of Six Sigma or experience leading continuous improvement projects.

Responsibilities

Supervise manufacturing activities for multiple products according to established operating procedures, delegating resources and participating in the process.
Train and mentor personnel in all facets of the manufacturing process.
Review executed batch records and logbooks before submitting them for final production review.
Reallocate personnel based on production needs.
Create weekly activity schedules to meet production needs.
Ensure equipment and supply inventories are maintained and available in accordance with production schedules.
Ensure only approved materials and equipment are used.
Ensure personnel perform only tasks for which they have accurate and approved training records.
Ensure only approved documentation and procedures are used.
Attend training programs required by company SOPs, procedures, and policies.
Perform other tasks and duties assigned by management.