Sr Mgr Manufacturing, Purification Operations

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role and Responsibilities:

The manufacturing manager schedules purification manufacturing activities based on the production schedule. These activities include solution and buffer preparation, cleaning and sterilization of process equipment, and operation of manual and automated purification systems (chromatography, tangential flow filtration, virus retentive filtration, depth filtration, and drug substance formulation). The manager sets expectations and provides guidance to team leads and operators related to cGMP manufacturing documentation, standard operating procedures, quality records, training, compliance, and safety.  The manager may serve as a project lead on cross functional projects or serve as a team representative on cross-functional projects.

Responsibilities include:

• Schedule purification manufacturing operations and ensure thorough communication and consistency of operations and expectations between manufacturing shifts.

• Development, training, and mentorship of employees. Responsible for performance management of direct reports.

• Ensure that operations are conducted in compliance with cGMPs.

• Interface with the Quality Assurance, Maintenance, Process Development, Technical Operations, Automation, Materials Management, and Validation departments for coordination of operations, lot disposition, troubleshooting, and projects.

• Manage or own quality system records including deviations, corrective and preventive actions (CAPA), change controls, etc.

• Serves as a functional representative and may lead cross functional teams for new product introduction and operational oversight

• Implement and reinforce practices that make safety an ongoing priority for all operational activities

• Lead cross-functional projects to improve operational efficiency, reliability, compliance, and safety.

• This is an exempt (salary) position that will include weekend and off hours coverage.

Knowledge, Experience and Skills:

• 8+ years of experience with Bachelor’s degree or 6+ years with Masters in science, engineering or related field is required

• Prior management experience in a Current Good Manufacturing Practices (cGMP) bioprocess environment is required

• Demonstrated influencer, including cross-functionally as well as senior leaders

• Quality systems, validation principles, regulatory guidelines, and multi-product controls

• Experience with large scale protein purification and distributed control systems (DCS) such as DeltaV and automated process equipment

• Background in disposable technology and multi-product facility desired

• Consistent positive attitude and demonstrated ability to learn new skills

• Strict adherence to established safety and compliance practices and standards

• Ability to think critically, with demonstrated troubleshooting and problem-solving skills as applicable to manufacturing process, documentation, and equipment. 

• Takes initiative in solving issues.

• Self-motivated and willing to accept temporary responsibilities outside of initial job description

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

• Able to work off hours as well as weekends as needed

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.