Manufacturing Team Lead,
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 team lead provides daily job assignments to manufacturing staff and will supervise/perform cGMP production activities on the manufacturing floor to support the production schedule. These activities include media and buffer preparation, maintenance of cell cultures in disposable flasks and fixed (stainless) and disposable bioreactors, centrifugation, and depth filtration. They also include Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP) of miscellaneous parts and equipment.
This is a 4/10 daytime shift that will include at least one weekend day
- Develop technical expertise in cell culture manufacturing and provide technical instruction/training on current and new/improved processes
- Development and training 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 on daily operations and projects.
- Manage or own quality system records including deviations, corrective and preventive actions (CAPA), change controls, etc.
- Regular review of documentation including batch records, logbooks, forms, and employee training records.
- Implement and reinforce practices that make safety an ongoing priority for all operational activities
- Provide support to integrate best practices, where appropriate, into manufacturing. Support improvement initiatives.
- Utilize ERP systems (Oracle EBS, SAP, etc.) for work order generation and inventory management of consumables, raw materials, and in-process materials.
- Utilize equipment/asset management systems to track and submit service requests.
- Support operations activities including cell banking and biologics production.
- Author/update standard operating procedures (SOP's) and master batch records (MBR's)
- May lead or serve as a functional representative on cross-functional projects
.Knowledge, Experience and Skills:
- 5+ years of experience with Bachelor's degree or 3+ years with Masters in science, engineering or related field is required
- Prior experience in a Current Good Manufacturing Practices (cGMP) environment is required
- Demonstrated leadership experience
- Excellent aseptic/sterile techniques and prior experience with biopharmaceutical manufacturing
- Quality systems, validation principles, regulatory guidelines, and multi-product controls
- Experience with 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
- Proficiency in routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, and cell counters
- 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
- Ability to lift 40 lbs repeatedly and stand for hours at time
- Able to work off-shift 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/GileadAbout 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.
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