Supervisor, Manufacturing - United States
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- The Clinical Manufacturing Supervisor will provide daily supervision of the clinical production team to ensure that production goals are met and area compliance is maintained.
- The Clinical Manufacturing Supervisor will have responsibility for the staff members and equipment in all clinical production areas (central services, cell culture, and purification).
- This position requires extreme flexibility as production and area maintenance activities are required 7 days per week.
- Production activities are typically performed Monday through Friday; however weekend production work may be required to meet company objectives.
- Motivate, recruit and develop key employees of varying levels of experience.
- Build and sustain employee engagement by fostering a culture of information, exchange, employee empowerment and an environment of continuous improvement.
- Plan daily production and support activities based on the clinical production schedule
- Provide on-the-floor supervision, instructional guidance and individual performance coaching while executing production operations alongside subordinate team members
- Ensure compliance to cGMP’s and improvement of SOPs and production batch records
- Ensure that staff training curricula continues to develop and that active levels are appropriately maintained
- Coordinate interactions to build a collaborative environment with internal departments and external contracts
- Develop annual objectives in alignment with corporate initiatives for each member of the clinical manufacturing team
- Effectively communicate status of operations to staff, peers and upper management in a timely and concise manner
- Focus on attaining site metric goals; actively develop tools to assure site metric goals are met
- Utilize the Integrated Management System to drive work efficiencies and to react to challenges in a production environment
- Authorize and revise SOPs and production batch records; author deviations and investigations
- Manage associate production coverage and determine own schedule based on the oversight required to appropriately mitigate risk
- Balance production schedule with Technology Transfer objectives, preventive maintenance / metrology schedule, and continuous improvement initiatives
- Ensure compliance with area procedures
- Define, champion and implement continuous improvement initiatives
- Balance workload effectively among the clinical production team members and ensure continuation of cross-training efforts
- Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
- Must be knowledgeable of pharmaceutical and/or biotech manufacturing processes and their translation into documentation such as batch records and SOPs
- Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems.
- Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
- Must possess strong verbal and written communication skills
- Familiarity with regulatory inspection process
- Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in Biology, Chemistry, Chemical Engineering or related discipline
- Three or more years of cGMP experience preferred; consideration will be given to other relevant experience and educations
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes 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, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas