Aseptic Manufacturing Supervisor (2nd Shift)

Job Description

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

Bachelors 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.