Supervisor, Manufacturing; Back End Day Shift

Supervisor, Manufacturing (Back End Day Shift)

United States - Maryland - Frederick Regular

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 fulfil their aspirations. Join Kite and help create more tomorrows.

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
• BA / BS Degree with 5+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience
• Associate and 7+ years of cGMP Manufacturing and/or Manufacturing Leadership and/or Operations experience
• 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…