Supervisor, Manufacturing (Back- End Swing Shift) at Gilead in Frederick, MD

Job description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Kite and help create more tomorrows. Job Description We are seeking a highly effective Supervisor, Manufacturing to be responsible for supervising a team of cell therapy manufacturing specialists in our 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 developing a team, and providing the necessary training and ongoing coaching, performance management and recognition of direct staff, including performing annual performance reviews. **This position is for Back-end Swing shift (Wednesday to Saturday, from 3:00PM to 01:30 AM)* Responsibilities of the Supervisor of Cell Therapy Manufacturing include: Provide oversight and/or supervision for the on-the-floor operations of cell therapy manufacturing in a cGMP environment. Build a team, provide leadership, guidance, and necessary training to staff in alignment with cGMP requirements. Support the review and approval of procedural changes within controlled documentation. Clear communication with outgoing and incoming shift supervisors to disseminate all relevant information. Support the review and approval of procedural changes within controlled documentation. Participate in multi-functional project teams, as necessary. Responsible for oversight of on-the-floor execution of protocol driven production activities within manufacturing (APVs, PPQs, Engineering Runs, etc.) Execute production and resource schedule against operational plan Ensure performance of all process steps are in compliance with applicable SOPs, policies, and governing documents. 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. Take corrective action to bring about required changes using change control procedures. Support cross-functional meetings to ensure manufacturing representation as needed. Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed. 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 Associate and 7+ 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