Supervisor, Manufacturing - 12-Hr Day Shift 2-2-3

Alcami Corporation • Morrisville, NC

7h • Onsite

About The Position

The Manufacturing Supervisor is accountable for results in a fast-paced environment and maintains product quality by supporting GMP operations for sterile injectable drug products intended for clinical trials and commercial distribution. The role operates in accordance with established Standard Operating Procedures (SOPs), approved Batch Records, regulatory expectations, and current Good Manufacturing Practices (cGMPs). The supervisor oversees Manufacturing Technicians, promotes acceptable cleanroom techniques, demonstrates proficiency in department procedures, and provides manufacturing updates to area management.

This is a 100% on-site role on a 12-hour rotating day shift schedule (2-2-3), from 7:00 a.m. to 7:00 p.m. The supervisor leads a manufacturing team of 4–12 direct reports and supports manufacturing activities, quality investigations, corrective and preventive actions, batch release, and hiring.

Requirements

• High school diploma or GED required.
• At least two years of hands-on work experience in a regulated cGMP environment.
• Previous experience with cGMP drug product manufacturing required.
• General knowledge of current Good Documentation Practices and the ability to legibly document activities in real time according to area SOPs.
• Strong attention to detail and ability to detect minute defects or discrepancies in product appearance.
• Excellent communication and interpersonal skills, including the ability to train and certify employees.
• Ability to work independently and collaboratively in a fast-paced environment.
• Flexibility to adapt to changing priorities, variable capacities, and batch-to-batch operational changes.
• Basic computer skills, including Microsoft Office.
• Ability to travel domestically up to 5%.
• Visual acuity and color vision sufficient to identify product defects and discrepancies.
• Ability to stand for extended periods and perform repetitive manipulations while handling syringes, vials, and lyophilized products.
• Ability to lift up to 10 pounds frequently and occasionally lift or move up to 50 pounds with assistance.
• Good manual dexterity and hand-eye coordination.
• Ability to work in cleanrooms and controlled manufacturing environments and use disinfectants and sporicides.
• Ability to use personal protective equipment, including face masks, Powered Air Purifying Respirators (PAPRs), and Supplied Air Breathing Respirators (SABRs), with required training and medical evaluation.

Nice To Haves

• Bachelor’s degree preferred.
• Knowledge of pharmaceutical manufacturing and batch record review preferred.
• Experience with light inspection booths, light meters, or TAPPI charts is highly desirable.
• Experience with filter integrity testers or steam sterilizers (autoclaves) is highly desirable.
• Experience with general compounding equipment, including pH meters, mixers, stir plates, and rigid or soft vessels, is highly desirable.
• Experience with single-use solution pathway parts, including aseptic connectors and filtration assemblies, is highly desirable.
• Experience with drug product fillers, including isolators, is highly desirable.
• Familiarity with electronic documentation systems is a plus.

Responsibilities

• Follow established SOPs and cGMPs to execute manufacturing protocols and procedures in compliance with regulatory requirements and company standards.
• Ensure timely completion of cGMP and other required company training.
• Oversee and perform manufacturing activities, including area sanitization and cleaning, equipment preparation, dispensing, compounding, filtration, isolator aseptic filling, and visual inspection.
• Communicate clearly and effectively with manufacturing and cross-functional teams, including technicians and management.
• Directly supervise 4–12 manufacturing employees and drive shift performance, including training and development, coaching and mentoring, engagement, retention, and performance management.
• Maintain personnel timekeeping and time-off requests to support uninterrupted departmental operations.
• Collaborate with cross-functional teams to address quality issues and implement process improvements.
• Support departmental work such as releasing clinical and commercial manufacturing batches, conducting and completing investigations, and completing corrective and preventive actions.
• Assist with hiring manufacturing technicians and other site employees.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED