Manufacturing Supervisor

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Manufacturing Supervisor is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution. The Manufacturing Supervisor operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs). The Manufacturing Supervisor oversees a team of Manufacturing Technicians and ensures utilization of acceptable cleanroom techniques while working in manufacturing/inspection environments and is expected to demonstrate proficiency in all department procedures and provide manufacturing updates to area management.

On-Site Expectations

• 100% on-site position.
• Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am.

Responsibilities

• Follow established SOPs and cGMPs to execute protocols and procedures for manufacturing operations, ensuring compliance with regulatory requirements and company standards.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Oversee and perform manufacturing activities, including but not limited to area sanitization/cleaning, equipment preparation, dispensing, compounding, filtration, isolator aseptic filling and visual inspection.
• Clearly and effectively communicate with manufacturing and cross-functional teams, including technicians and management.
• Directly supervise manufacturing team of 4-12 direct reports and drive overall performance of the manufacturing shift, including training and development, coaching/mentoring, engagement, retention and performance management of a high performing team to meet the current and evolving needs of the site.
• Maintains personnel timekeeping and time-off requests to ensure uninterrupted operations of the department.
• Collaborate with cross functional teams to address quality related issues and implement process improvements.
• Support manufacturing department related duties, including but not limited to, release of clinical and commercial manufacturing batches, performing and completing investigations, and completion of corrective and preventive actions.
• Assist in hiring process of manufacturing technicians and other employees at the site.
• Other duties as assigned.

Qualifications

• High School Diploma or GED required. Bachelor’s degree preferred.
• Two (2) years or more of hands-on working experience in a regulated (cGMP) environment. 
• Previous experience with cGMP Drug Product manufacturing required.

Knowledge, Skills, and Abilities

• General knowledge of current Good Documentation Practices (GDP) and ability to legibly document activities performed in real time per area SOPs. 
• Knowledge of pharmaceutical manufacturing and review of batch records preferred. 
• Experience with any of the following equipment is highly desirable:
  • Light inspection booths, light meters and TAPPI charts
  • Filter integrity testers, steam sterilizers (autoclaves) 
  • General compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels)
  • Single-use solution pathway parts including aseptic connectors and filtration assemblies
  • Drug Product fillers including isolators
• Strong attention to detail and the ability to detect minute defects or discrepancies in product appearance.
• Excellent communication and interpersonal skills, with the ability to effectively train and certify employees.
• Ability to work independently and collaboratively in a fast-paced environment.
• Flexibility to adapt to changing priorities and support operations at variable capacities. Ideal candidates must readily adapt to variable operations required batch to batch.
• Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is a plus.

Travel Expectations

•  Up to 5% domestic travel.

Physical Demands and Work Environment

• Visual acuity and color vision are essential for accurately identifying defects and discrepancies in product appearance.
• Employees are regularly required to stand for extended periods while performing inspections and/or supporting manufacturing operations.
• Job may require repetitive manipulations while handling syringes, vials and lyophilized products.
• Ability to lift up to 10 pounds frequently and occasionally lift/move up to 50 pounds (with assistance).
• Technicians must have good manual dexterity and hand-eye coordination to work safely within a GMP manufacturing space.
• Area sanitization requires the use of disinfectants and sporicides. 
• Visual inspection and operational support occur in cleanrooms and controlled manufacturing environments. This may include exposure to wet and/or humid conditions with moderate noise level at times. Work areas remain well-lit with proper ventilation and temperature control to support operator comfort and maintain product quality/integrity.
• Supervisors may be exposed to pharmaceutical products, chemicals, and potentially hazardous substances with the use of personal protective equipment such as face masks, Powered Air Purifying Respirators (PAPRs), and Supplied Air Breathing Respirator (SABRs) with necessary training and medical evaluation.