Sr. Supervisor, Manufacturing - 3rd Shift

 

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 Senior Supervisor, Manufacturing 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 Senior 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 Sr. Supervisor, Manufacturing 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.
• 3rd Shift: Sunday - Thursday, 11:00pm - 7:30am.

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.
• 4+ years of hands-on working experience in a regulated (cGMP) environment.
• 2+ years of leadership experience.
• Previous experience with cGMP Drug Product manufacturing required.

Knowledge, Skills, and Abilities

• Bullet list of job specific KSAs.
• 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

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable indi