Supervisor, Manufacturing (Back- End Swing Shift)

Kite Pharma•Frederick, MD

1d•Onsite

About The Position

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)

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

Nice To Haves

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 deep sense of ownership in areas of responsibility

Responsibilities

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.