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.

Are you interested in joining our team?

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.

• 100% on-site position.
• 3rd Shift: Sunday - Thursday, 11:00pm - 7:30am.

• 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.

• 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.

• 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.

•  Up to 5% domestic travel.

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 individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.