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

Alcami Corporation•Morrisville, NC

8h•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 a team of Manufacturing Technicians, ensures appropriate cleanroom techniques, demonstrates proficiency in department procedures, and provides manufacturing updates to area management. This is a 100% on-site position on a 12-hour rotating night shift (2-2-3), from 7:00 p.m. to 7:00 a.m. Domestic travel may be up to 5%.

Requirements

High school diploma or GED required.
At least two years of hands-on work experience in a regulated cGMP environment.
Previous experience in cGMP drug product manufacturing required.
General knowledge of current Good Documentation Practices (GDP) and ability to document activities legibly 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, with the ability to train and certify employees effectively.
Ability to work independently and collaboratively in a fast-paced environment.
Flexibility to adapt to changing priorities and variable operating capacities from batch to batch.
Basic computer skills, including Microsoft Office.
Ability to perform work requiring visual acuity and color vision, extended standing, repetitive manipulation of syringes, vials, and lyophilized products, and good manual dexterity and hand-eye coordination.
Ability to lift up to 10 pounds frequently and occasionally lift or move up to 50 pounds with assistance.
Ability to work with disinfectants and sporicides and, with required training and medical evaluation, use personal protective equipment such as face masks, PAPRs, and SABRs.

Nice To Haves

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

Responsibilities

Follow established SOPs and cGMPs when executing manufacturing protocols and procedures, ensuring compliance with regulatory requirements and company standards.
Ensure timely completion of cGMP and other relevant company training requirements.
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 team members and drive shift performance through training and development, coaching and mentoring, engagement, retention, and performance management.
Maintain personnel timekeeping and time-off requests to support uninterrupted department operations.
Collaborate with cross-functional teams to address quality issues and implement process improvements.
Support department duties, including release of clinical and commercial manufacturing batches, investigations, and corrective and preventive actions.
Assist with hiring manufacturing technicians and other site employees.
Perform other duties as assigned.