Supervisor, PDS Sterile Manufacturing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, you’ll do meaningful work that makes a positive impact on a global scale. Join our team and help bring our Mission to life every day—enabling our customers to make the world healthier, cleaner, and safer. We empower our employees with the resources and opportunities to achieve their career goals while developing innovative solutions to some of the world’s toughest challenges, from protecting the environment to ensuring food safety and supporting the search for cancer treatments.

Position Summary

We are seeking a PDS Sterile Manufacturing Supervisor to join our manufacturing operations team. In this role, you will lead and support production teams involved in sterile pharmaceutical manufacturing, ensuring operational excellence, product quality, and full compliance with cGMP standards and FDA regulations.This position combines strong technical expertise with people leadership. You will coordinate production activities, oversee manufacturing processes, and drive continuous improvement initiatives while fostering a culture of safety, quality, and accountability.

Key Responsibilities

• Supervise and coordinate daily sterile manufacturing operations

• Ensure compliance with cGMP, FDA, and company quality standards

• Monitor production performance and maintain adherence to schedules

• Review batch records and ensure accurate documentation

• Lead, coach, and develop manufacturing team members

• Support investigations, deviations, and corrective actions

• Promote a strong culture of safety, quality, and continuous improvement

• Collaborate cross-functionally with Quality, Engineering, and other departments

• Identify and implement process and operational improvements

Education

• Bachelor’s degree in Science, Engineering, Chemistry, Economics, Business or a related STEM field (preferred)

• Equivalent combinations of education and experience (i.e. high school diploma and at least 7 years of sterile manufacturing experience)

Experience

• 3+ years of experience in pharmaceutical or biotechnology manufacturing,

• 2+ years of supervisory or leadership experience in a GMP-regulated environment

Preferred Qualifications

• Strong knowledge of cGMP regulations and FDA requirements

• Experience with aseptic processing and cleanroom operations

• Familiarity with environmental monitoring and aseptic techniques

• Experience with batch record review and manufacturing documentation

• Knowledge of Lean, Six Sigma, or other continuous improvement methodologies

• Strong project management and organizational skills

• Ability to manage multiple priorities in a fast-paced environment

• Experience driving operational excellence and quality improvements

• Proficiency with Microsoft Office and manufacturing systems

• Excellent written and verbal communication skills

• Strong interpersonal skills and ability to work cross-functionally