Director Biologics Manufacturing Operations
Director Biologics Manufacturing Operations
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. Gileads 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 companys five core values. Thats 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, 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:
Gilead has an opportunity for an experienced Director of Manufacturing Operations at our Oceanside biologics facility in Southern California. We are seeking motivated, team-oriented leaders with expertise in manufacturing of recombinant proteins. Reporting to the Sr. Director of Manufacturing and Support Operations, you will have the opportunity to lead cell culture, purification and cell bank manufacturing teams.
Specific responsibilities and skills for position:
- Lead Gilead's Biologics Manufacturing Operations organization that is responsible for cell bank generation and drug substance production of recombinant proteins
- Provide strategic and technical leadership to the upstream, downstream and technical training teams
- Direct the activities of the manufacturing operations group including defining, planning and implementing activities/projects related to cell banking, cell culture, purification, media and buffer prep operations to ensure production schedules are met
- Identify and implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
- Provide leadership to cross-functional teams and drive business process improvements related to manufacturing operations and future expansion
- Direct the development of manufacturing projects and initiatives, determine metrics for success and evaluate performance against metrics
- Partner with Gilead Biologics Process Development, Quality, Technical and Support Operations to ensure timelines, deliverables, and business operations are aligned and met
- Represent the department as a member of a cross-functional project team providing guidance, insight and recommendations relative to the goals and objectives of the Manufacturing operations function
- Comply with safety and environmental rules and regulations applicable to the operations
Essential Duties and Job Functions:
- Accountable for both personnel and task management
- Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)
- Manages key relationships with external stakeholders
- Ensures adherence to budgets, schedules, and performance requirements
Knowledge, Experience and Skills:
- 12+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 10+ years of relevant experience and an advanced science degree such as MS, PhD or an advanced business degree such as an MBA
- Has extensive experience in biotech or pharmaceutical industry
- Signification experience with upstream and downstream bioprocessing equipment and operations from cell banking to thaw through harvest, protein purification and drug substance fill
- In-depth understanding of cGMP requirements for clinical manufacturing, proven experience in supporting regulatory and site inspections
- Demonstrates in-depth knowledge of industry best practice and trends
- Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs)
- Demonstrates excellent verbal, technical writing, and interpersonal communication skills
- Demonstrated influencer, including cross functionally and senior leaders
- Demonstrates strong project participation and leadership skills
- Demonstrates the ability to work effectively in cross-functional teams
- Has proven prior people management experience
- Solid background in upstream and downstream GMP operations
- Background in disposable technology and multi-product facility is preferred
- Prior experience in Drug Substance MFG, MSAT, and QA is preferred
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.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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