Supervisor, Manufacturing

Gilead Sciences•Frederick, MD

1d•$107,185 - $138,710•Onsite

About The Position

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.

Requirements

Master’s and 3+ years of relevant experience OR Bachelor’s and 5+ years of relevant experience

Nice To Haves

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

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