Supervisor, Manufacturing

Gilead Sciences • Frederick, MD

19h • $107,185 - $138,710 • Onsite

About The Position

Kite is seeking a Supervisor, Manufacturing to lead a team of cell therapy manufacturing specialists at its commercial biotechnology facility in Frederick, Maryland. The role supervises on-the-floor manufacturing operations in a cGMP environment and includes team development, training, ongoing coaching, performance management, recognition, and annual performance reviews.

The supervisor supports routine biologics manufacturing by generating and maintaining relevant production documentation, executing production and resource schedules, ensuring process steps are performed, monitoring processes and reviewing manufacturing records. The role also investigates and resolves problems, identifies root causes, proposes improvements, works with vendors and senior management, and participates in cross-functional projects and change-control activities.

This is a Front-end Swing shift position scheduled Sunday through Wednesday, 3:00 p.m. to 1:30 a.m. Off-shift work and participation in an on-call rotation may be required; weekend shifts are likely.

Requirements

• Master’s degree and at least 3 years of relevant experience, or a bachelor’s degree and at least 5 years of relevant experience.
• Able to work off-shift hours and participate in an on-call rotation as needed; weekend shift work is likely.
• Excellent interpersonal, verbal, and written communication skills.

Nice To Haves

• Ability to build and lead a team and train entry-level personnel.
• Knowledge of current Code of Federal Regulations (CFRs) and current Good Manufacturing Practices (cGMPs).
• Understanding of processes, systems, and equipment sufficient to troubleshoot problems and provide solutions to senior management.
• Knowledge of electronic quality systems.
• High energy, positive outlook, and a can-do attitude, with willingness to work toward personal and organizational goals and overcome obstacles.
• Willingness to think outside the box and adapt best practices to a small, 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 is preferred or highly desired.

Responsibilities

• Supervise on-the-floor operations at a commercial cell therapy manufacturing facility in a cGMP environment.
• Build and lead a team; provide training, ongoing coaching, discipline, and recognition to direct staff, and conduct annual performance reviews.
• Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacturing.
• Execute production and resource schedules against the operational plan.
• Ensure performance of all process steps specific to the phase or stage of operation.
• Monitor processes, including manipulating databases, documents, and spreadsheets to support business reporting requirements.
• Review completed manufacturing documentation in accordance with compliance standards and established timelines.
• Investigate and resolve problems, identify root causes, and propose process improvements through clear communication to senior management.
• Interact with outside vendors and senior management.
• Participate in multifunctional project teams as needed.
• Take corrective action to bring about required changes using change-control procedures.
• Perform other duties as assigned.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager