Job DescriptionWe 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 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
Does this sound like you? If so, apply today!
The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 [redacted] on Twitter at www.twitter.com/kitepharma.
For Current Kite Pharma Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.
