Supervisor, Manufacturing Central Services (Day Shift) - United States
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The Manufacturing Supervisor will provide daily supervision of the commercial Central Services manufacturing team to ensure that safety and production goals are met and area compliance is maintained. The Manufacturing Supervisor will have responsibility for the staff members and equipment in commercial equipment preparation and weigh & dispense areas.
- Maintains a safe working environment and reports incidents/accidents to site leadership and EH&S immediately.
- Assigns daily duties and tasks to all team members and ensures execution of manufacturing activities in strict accordance with production batch records, standard operating procedures and cGMP.
- Manages and develops the performance of direct reports by setting effective goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for performance.
- Escalates production floor issues related to safety, personnel or process to management and/or appropriate functional area(s).
- Provides working knowledge and technical leadership in manufacturing operations.
- Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
- Ensures manufacturing areas are inspection ready at all times.
- Promotes “Right First Time” philosophy for all manufacturing activities.
- Provide on-the-floor supervision, instructional guidance and individual performance coaching while executing production operations alongside subordinate team members.
- Responsible for coordination of manufacturing activities across process steps, processing areas, and with other manufacturing shifts. The supervisor will also be responsible for arranging and coordinating the interaction of support functions with the manufacturing floor, (warehouse, maintenance, quality control, quality assurance and technical services).
- Operates complex systems and equipment in strict accordance with production batch records, standard operating procedures and cGMP.
- Performs batch record review.
- Supports and adheres to site scheduling processes.
- Demonstrates ability to troubleshoot basic mechanical and automation issues.
- Ensures manufacturing staff identify and document events that deviate from normal operation.
- Partners with Quality Assurance to identify events that are deviations and initiates deviation records.
- Supports Manufacturing Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for manufacturing owned deviations.
- Collects production performance data and performs trend analysis to identify areas of improvement.
- Applies advanced problem solving techniques to drive continuous improvement.
- Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
- Manages or supports plant floor continuous improvement initiatives.
- Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.
- Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
- Must have technical understanding of unit operations carried out in biological manufacturing including: equipment preparation and weigh & dispense activities.
- Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
- Must possess good interpersonal skills and the ability to communicate well, both verbally and written.
- The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner.
- Ability to use a respirator is a requirement of this position.
- A Bachelor Degree in a scientific discipline or equivalent is preferred.
- Minimum 6-8 years working in a cGMP biological manufacturing environment.
- Previous experience managing subordinates and/or leading project teams.
New Haven, CT, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer