Chromatography Senior Supervisor

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The Chromatography Manufacturing (Antibody Purification, Biotinylated Conjugates, and Lite Reagent Concentrates) Senior Supervisor position supervises 13 direct reports, manages weekend coverage of the work center, maintains cGMP compliance and adherence to site SOP’s, works cross-functionally, and represents Chromatography Manufacturing in cross-functional team meetings.

This position includes the handling of all types of materials, including biohazardous, hazardous, and DEA (Drug Enforcement Agency) controlled materials.

A Chromatography Manufacturing Senior Supervisor is responsible for:

• Supervising Chromatography Operators, Technicians, and Biochemists. 
• Purification, conjugation, and labeling of antibodies/antigens
• Maintaining cGMP compliance and adherences to site SOP’s
• Supporting and providing technical guidance to employees 
• Driving improvements in manufacturing processes
• Developing/coaching employees
• Auditing manufacturing documentation including but not limited to  Manufacturing Batch Records, Bills of Materials, Routings, Process Documents, and SOP’s
• Working with Biochemists to coordinate and monitor day to day assignments of the group
• Support training/training development of manufacturing processes
• Reviewing and approving employee Timecards and PTO requests to ensure adequate staffing to meet scheduled demands.
• Representing Chromatography Manufacturing in cross functional meetings including but not limited to element teams, planning and scheduling, and product troubleshooting.  
• Supporting and implementing Change Control Projects as appropriate
• Authoring, Reviewing, and Approving Quality System documentation including but not limited to Quality Notifications (QN’s), Temporary Manufacturing Deviations (TMDs). Corrective and Preventive Actions (CAPA’s), and Change Impact Assessment (CIA’s)
• Providing training to employees for quality system documentation
• Back-filling on the manufacturing floor to meet work center demands
• Fostering a diverse and inclusive environment as part of world class team

Required Knowledge/Skills, Education, and Experience

• Bachelor’s Degree in Life Science discipline. (Biology, Chemistry, Engineering, or other applicable Science Degree)
• 3-5 years chromatography work experience. 
• 5-7 years’ experience working in a similar supervisory or leadership role in the medical diagnostic/ medical device industry
• Strong understanding of cGMP manufacturing in a controlled environment, as well as an understanding of ISO requirements. 
• Solid understanding of the use of laboratory equipment used in manufacturing and witnessing manufacturing batch records.
• Experience executing troubleshooting and investigation work, as well as associated outcomes.
• Effective communication skills, both verbal and in written form. The ability to communicate is critical to the successful delivery of information to customers and the team, with regards to priorities and expectations. 
• Excellent time management skills 
• Ability to meet multiple commitments, for both the daily manufacturing deliverables, as well as the mid to long term projects. 
• Ability to present information in technical or scientific writing format.
• Ability to provide guidance and leadership
• Must pass a Drug Enforcement Agency (DEA) background check.

Preferred Knowledge/Skills, Education, and Experience

• Experience with AKTAs
• A solid technical background in manufacturing processes
• A background with program development/modification
• Experience working with automated manufacturing equipment. 
• Prior experience manufacturing commercialized automated immunoassays and/or ELISA and chemiluminescent products
• Working knowledge of Lean and other Continuous Improvement philosophies and techniques
• Proficiency with Microsoft Office