Hiring company: Kite Pharma
*** We are ramping up for commercial production - numerous positions available! If you have been thinking about a new job, now is a great time to apply! **
Both Day Shift and Swing Shift positions are currently available.
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, Cell Therapy 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.
Responsibilities of the Supervisor, 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
#MFG123MD
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.