Aseptic Manufacturing Supervisor (2nd Shift)

Scope of Position

The Fill/Finish Supervisor oversees GMP manufacturing processes, focusing on the aseptic production of finished biologic drug products for Phase I/II and commercial GMP manufacturing. This hands-on role involves leading a team of technicians, ensuring compliance with industry regulations, and maintaining operational efficiency and product quality. This is a third-shift position.

Responsibilities

• Supervise and lead a team of manufacturing technicians, providing guidance and support.
• Ensure all projects comply with cGMP regulations, safety standards, and established protocols.
• Oversee the production of clinical and commercial materials, meeting strategic objectives and quality benchmarks.
• Conduct on-the-job training to enhance staff skills and maintain aseptic qualifications.
• Assign tasks and coordinate emergency responses during shifts.
• Ensure accurate documentation of processes, including batch records and standard operating procedures (SOPs).
• Collaborate with cross-functional teams, including Quality Assurance (QA) and Manufacturing, to optimize processes and resolve issues.
• Support scale-up and trial-run projects by providing hands-on assistance during manufacturing.
• Monitor product stability and conduct shelf-life testing.
• Prepare and review material purchase orders and equipment load lists.
• Document field conditions, project updates, and deviations from standard processes.
• Conduct safety inspections, report incidents, and implement corrective actions.
• Provide performance reviews, set annual goals, and conduct one-on-one mentoring sessions.
• Identify and implement continuous improvement initiatives.
• Perform other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Science, or a related field.
• 5-8 years of experience in GMP manufacturing operations, preferably in fill/finish processing.
• Strong knowledge of aseptic filling, pharmaceutical manufacturing, and the drug development process.
• Proven track record of supervising GMP manufacturing operations and leading teams.
• Familiarity with electronic Quality Management Systems (e.g., MasterControl, Trackwise).
• Ability to interpret construction drawings, specifications, and process parameters.
• Strong problem-solving skills and the ability to make informed decisions with minimal supervision.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, etc.).
• Excellent communication and organizational skills.
• Ability to work effectively in cross-functional teams and foster a collaborative work environment.

Physical Demands

• Ability to travel between facilities as needed.
• Capable of sitting, standing, climbing stairs/ladders, and lifting up to 40 pounds.
• Willingness to use personal protective equipment (PPE) when required.

Preferred Skills

• Experience with regulatory standards, including FDA and international guidelines.
• Ability to analyze complex data and implement solutions.
• Demonstrated leadership skills with a focus on mentoring and team development.
• Commitment to continuous improvement and operational excellence.