Manufacturing Team Lead, Downstream Facility Readiness
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:
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to apply for this job.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 team lead will be responsible for activities associated with equipment selection and readiness for a new biologics Drug Substance (DS) manufacturing facility. This position will lead downstream equipment detailed design, selection, commissioning, and documentation deliverables (URSs, SOPs, etc.) associated with the start up of a new single use clinical manufacturing facility. This position will contribute to other GMP readiness deliverables such as training, qualification and validation support, engineering runs, automation requirements, determination of spare parts and Maintenance intervals, and troubleshooting. Areas of responsibility will include solution and buffer preparation, operation of manual and automated purification systems (buffer/fluid management, chromatography, tangential flow filtration, virus retentive filtration, depth filtration, and drug substance formulation). The lead sets expectations and provides guidance to team members and operators related to detail design of equipment and facility, cGMP manufacturing documentation, standard operating procedures, quality records, training, compliance, and safety. The lead may serve as a project lead on cross functional projects or serve as a team representative on cross-functional projects.Responsibilities include: Lead equipment detailed design, selection, commissioning, and documentation deliverables associated with the start up of a new single use manufacturing facility
Develop technical expertise in biologics downstream (purification) manufacturing and provide technical instruction/training on current and new processes
Design and align with cross functional groups on standardizing consumable designs and implementation.
Development and training of employees. May be responsible for performance management of direct reports.
Ensure that operations are conducted in compliance with cGMPs (current Good Manufacturing Practices).
Interface with the Quality Assurance, Maintenance, Process Development, Technical Operations, Automation, Materials Management, and Validation departments, among others, 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 and recommend studies for improvements.
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 drug substance production.
Author/update user requirement specifications (URS), commissioning protocols, 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:
6+ years of experience with Bachelor's degree or 4+ 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 technical competency in biologics drug substance purification equipment 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 operation of single-use equipment including but not limited to: mixing vessels, chromatography skids, TFF skids, filtration systems, etc
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/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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.