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:




Minimum 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 settingHigh School Diploma or GED with 6+ years of life science manufacturing experience in a cGMP setting1+ year of Management, Supervisory, or Lead experience



Preferred Qualifications:



3 years of Management, Supervisory or Lead experience in GxP envioronmentCustomer interfacing audit experienceKnowledge of Six Sigma concepts/Lean Manufacturing or process improvement Familiarity with large scale cGMP process equipment, tangential flow and chromatography automationStrong Microsoft Office experience for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reportsStrong interpersonal skills, conflict resolution experience, written, and verbal communication skills