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.
