Supervisor, Manufacturing
Gilead Sciences
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
- 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
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Paid time off
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.