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Posted 23 Feb 2024
St. Louis, Missouri - United States
Req Id 272312
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
At MilliporeSigma at our 3300 S. Second location, as the cGMP Manufacturing Supervisor position you will work and support the area of Biologic Active Pharmaceutical Ingredients (API), including Antibody Drug Conjugates (ADCs).
- Lead a team of production scientists and operators in the scale-up, technology transfer, and execution of cGMP manufacturing.
- Develop employees’ knowledge and skills to improve performance and expand abilities as well as to coordinate the group’s efforts to assist meeting the departmental, company, and customer’s objectives.
- Oversee the manufacturing of processing aids, excipients, and Active Pharmaceutical Ingredients (API’s) regulated by the Food and Drug Administration and other regulatory bodies.
- Adhere to protocols consistent with, and established according to, current Good Manufacturing Practices.
- Work cross-functionally with Project Management, Technical Operations, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
- Interact with our customers’ project management, technical and quality teams.
- Maintain departmental goals and objectives in a safe manner and in compliance with all applicable federal, state, and company regulations (OSHA, EPA, FDA, EMA etc.).
- Responsible for the management of capital for equipment and facility improvements, including balancing the departmental budget.
- Support department efforts toward Process Improvement and company goals.
- Revise and approve procedures, batch records, and other documentation to ensure compliance with cGMP guidelines.
- Ensure employees remain current with all department and site training requirements.
- Lead root cause investigations and implement effective corrective and preventative actions related to manufacturing deviations.
- Provide leadership and support of safety initiatives within production operations to ensure compliance to OSHA requirements.
- Ensure tasks are done in accordance with approved site procedures, batch records and protocols.
- Rotating shift schedule within department, 1st, 2nd and 3rd
Who You Are:
Basic Qualifications:
- Bachelor’s Degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, etc.) with 2+ years of life science manufacturing experience in a cGMP setting
OR
- High School Diploma or GED with 6+ years of life science manufacturing experience in a cGMP setting
- 1+ year of Management, Supervisory, or Lead experience
Preferred Qualifications:
- 3 years of Management, Supervisory or Lead experience in GxP envioronment
- Customer interfacing audit experience
- Knowledge of Six Sigma concepts/Lean Manufacturing or process improvement
- Familiarity with large scale cGMP process equipment, tangential flow and chromatography automation
- Strong Microsoft Office experience for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports
- Strong interpersonal skills, conflict resolution experience, written, and verbal communication skills
RSRMS
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
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