Supervising Pharmacist – 503B Manufacturing

Supervising Pharmacist – Pharmaceutical Manufacturing

Location: Maryland Heights, MO

Job Type: Full-Time | Onsite | Direct Hire (TBC)

Salary: $104k-$135k (TBC)

Shift: TBC

Industry: Pharmaceutical Manufacturing / 503B Outsourcing Facility

Recruiting Agency: Kelly Science & Clinical

Position Overview

Kelly Science & Clinical is seeking an experienced Supervising Pharmacist for a confidential pharmaceutical client in Maryland Heights, Missouri .

This role will oversee the safe, compliant, and efficient production of sterile and non-sterile compounded drug products within a 503B Outsourcing Facility. The Supervising Pharmacist will provide hands-on leadership across compounding operations, quality, production, training, and regulatory compliance.

Key Responsibilities

• Oversee daily sterile and non-sterile compounding operations, including line clearance, batch record review, and production scheduling.

• Ensure compliance with FDA 503B requirements, cGMP regulations, USP standards, and applicable state pharmacy laws .

• Review and approve Master Batch Records (MBRs), Batch Production Records (BPRs), and product release documentation .

• Ensure proper ordering, receiving, storage, inventory management, and reconciliation of drug substances.

• Oversee labeling, packaging, final product verification, and product release activities.

• Implement continuous improvement initiatives, production metrics, and workflow optimization.

• Support product development and R&D batch production as needed.

• Oversee training and competency evaluations for cleanroom and compounding personnel.

• Participate in hiring, onboarding, coaching, and performance management of pharmacy staff.

• Maintain required state licenses and pharmacy permits and ensure ongoing regulatory compliance.

• Provide subject matter expertise on complex compounding, clinical, and production-related issues.

• Partner with Quality Assurance on investigations, product release strategies, deviations, and complaint management.

• Develop and maintain SOPs, technical documentation, deviation reports, and investigation documentation.

Required Qualifications

• PharmD or RPh degree/license.

• Active pharmacist license in good standing with the applicable State Board of Pharmacy.

• 3+ years of sterile and/or non-sterile compounding experience.

• At least 1 year of supervisory or leadership experience in a pharmacy, compounding, or pharmaceutical manufacturing environment.

• Hands-on experience with sterile compounding and aseptic processing .

• Working knowledge of FDA cGMP, 503B requirements, USP <797>, and USP <800> .

• Strong understanding of pharmaceutical quality and compliance requirements.

• Excellent leadership, communication, documentation, and problem-solving skills.

• Proficiency with Microsoft Office and quality management systems (QMS).

Preferred Qualifications

• Previous experience in a 503B outsourcing facility .

• Experience with sterile injectable drug products .

• Experience with batch record review, product release, deviations, investigations, and CAPA.

• Experience developing and revising SOPs in a regulated pharmaceutical environment.

• Experience managing cleanroom personnel and compounding operations.

• Experience supporting regulatory inspections or maintaining state pharmacy permits/licenses.

Working Environment

This is an onsite position in Maryland Heights, MO . The role involves work within cleanroom, laboratory, office, and manufacturing areas.

The position requires:

• Regular exposure to aseptic environments and hazardous drug handling.

• Compliance with full gowning and cleanroom procedures.

• Standing for extended periods.

• Ability to lift up to 15 lbs.

• Strict adherence to environmental, safety, and pharmaceutical manufacturing protocols.

Interested?

If you are a licensed pharmacist with strong sterile compounding and leadership experience and are interested in taking on a key operational role within a growing pharmaceutical manufacturing environment, apply today or contact Kelly Science & Clinical to learn more.

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