Supervisor, Manufacturing
Kite Pharma
Summary
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.
Job description
This position is for Front-end Swing shift (Sunday to Wednesday, from 3:00PM to 01:30 AM)
Responsibilities
- Supervise the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment
- Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
- Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture
- 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 management
- Interact with outside vendors and senior management
- 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 Qualifications
Master’s and 3+ years of relevant experience OR Bachelor’s and 5+ years of relevant experience
Preferred Qualifications
- Able 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 quality systems
- Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely
- Excellent interpersonal, verbal and written communication skills are essential 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 best practices 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
- Previous cell culture experience preferred/highly desired
Requirements
- Master’s and 3+ years of relevant experience OR Bachelor’s and 5+ years of relevant experience
- 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 quality systems
- Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Able to build and lead a team as well as train entry-level personnel
- Previous cell culture experience preferred/highly desired
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Annual Bonus
- Stock-Based Long-Term Incentives
Company overview
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.