Aseptic Manufacturing Supervisor

The Aseptic Supervisor Fill/Finish is responsible for supporting the overall GMP Fill Finish manufacturing processes through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II & commercial GMP manufacturing.

Salary: $100k-$125k annually

Schedule:

1st shift: M-F 7 AM- 4 PM

2nd shift: M-F 3 PM- 12 AM

3rd shift: Sunday-Thursday- 11 PM- 8 AM

Responsibilities:

• Lead a team of manufacturing technicians.
• Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs and safety regulations.
• Performs training with staff on the floor, as needed.
• Point person on shift to assign/distribute the work and coordinate emergency situations.
• Performs training with staff on the floor, as needed.
• Maintain aseptic qualification training.
• Support and demonstrate skill set to Manufacturing Technicians I, II, and III.
• Ensure documentation (batch records and SOPs) are accurate and updated as required.
• This role is responsible for the accurate, safe, environmentally responsible, and quality-compliant operations of the manufacturing process.
• Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improvement.
• Recommends equipment and supply purchases within the production areas.
• Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions)
• Responsible for shift schedule and summarizing shift progress at the end of the shift.
• Lead and mentor staff. Write performance reviews and annual goals and hold one-on-ones.
• Effectively communicate results of departmental work through team discussions and documentation
• Ensure cGMP compliance and all its related elements in documentation, reports, and records.
• Initiate non-conformances when identified and complete investigations to support on-time closure of deviation.
• Understand and review current regulations, industry guidance, and other applicable professional documentation.
• Additional duties, as assigned.

Qualifications:

• B.S. in Engineering or Science discipline and a minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations, related technical field, or equivalent industry experience. (Some or all this experience should be in fill/finish processing), or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Experience with GMP fill finish operations and sound understanding of the drug development process.
• Aseptic Filling or Pharmaceutical Manufacturing experience: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices.
• Has considerable knowledge/expertise relevant to fundamental Fill/Finish manufacturing operations.
• Has sound understanding and knowledge of all fill finish operations, including aseptic hand filling and automated filling of liquid vials.
• Demonstrated track record of leading or supervising hands-on cGMP manufacturing operations.
• Demonstrate skill/experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC, MC, and other manufacturing groups) to maintain internal and project schedules.
• Demonstrated ability to motivate and mentor peers, staff, and foster a culture of continuous improvement and operational excellence.
• Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrated knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Demonstrated thorough understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate experience with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrated ability to execute a task, unit operation, and/or document (forms and/or SOPs) with little to no assistance.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.

•Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

• Ability to lift up to 40 pounds on occasion.

• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).