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Supervisor, Cell Therapy Manufacturing

United States - Maryland - FrederickManufacturing Operations & Supply ChainRegular

Job Description (Translated)

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?! We are seeking a highly effective Supervisor, cGMP Manufacturing to be responsible for supervising a team of cell therapy manufacturing specialists in our brand new, state-of-the-art commercial biotechnology facility in Frederick, MD. In this role, the Supervisor will supervise the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment including building a team, and providing the necessary training and ongoing coaching, performance management and recognition of direct staff, including performing annual performance reviews. Cell Therapy Specialist teams are working 7 Days a week in 4-day shifts. One team works Sunday – Wednesday and the other team works Wednesday – Saturday. Hours are 6:00 am to 4:30 pm ​.  Responsibilities of the Supervisor of cGMP Cell Therapy Manufacturing include: Supervise the on-the-floor operations of commercial cell therapy manufacturing facility in a cGMP environment Build a team, Provide leadership, guidance, and necessary training to staff in alignment with cGMP requirements. Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture Clear communication with outgoing and incoming shift Supervisors to disseminate all relevant information. Execute production and resource schedule against operational plan Ensure performance of all process steps specific to the phase or stage of operation Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements Review of completed manufacturing documentation per compliance standards and established timelines Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior leadership Participate in multi-functional project teams, as necessary Take corrective action to bring about required changes using change control procedures Other duties as assigned Basic Requirements: MA / MS with 3+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience OR BA / BS Degree with 5+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience OR High School Degree with 9+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience Preferred Qualifications: 5+ years of experience supervising staff 9+ years of experience in manufacturing in a biotech/pharma industry Proven capability to build and lead a team as well as train entry-level personnel Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management Sufficient knowledge of electronic batch record, ERP and quality systems Able to work evening to late mid night hours as well as part of the on-call rotation as needed is required; partial weekend shift Excellent interpersonal, verbal and written communication skills are important in this collaborative work environment High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles Willingness to think outside of the box and adapt standard methodologies to our small, but growing environment Ability to adapt in a constantly evolving environment Self-motivated with a strong sense of ownership in areas of responsibility Does this sound like you? If so, apply today! #LI-ML1 #IND123