Associate Director, Biologics Downstream Manufacturing

Oceanside, CA
Nov 26, 2021
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Biologics Downstream Manufacturing
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, 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 Associate Director of Downstream 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 Director of Manufacturing, you will have the opportunity to lead the purification manufacturing team.

Specific responsibilities and skills for position:
  • Lead Gilead's Biologics Downstream Manufacturing team that is responsible for drug substance purification and formulation of recombinant proteins
  • Provide strategic and technical leadership to the downstream team
  • Direct the activities of the Downstream Manufacturing operations group including defining, planning and implementing activities/projects related to purification, buffer prep, campaign readiness, and product changeover 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 downstream 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:
  • 10+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 8+ years of relevant experience and an a MS
  • Has extensive experience in cGMP related biotech or pharmaceutical industry
  • Significant experience with downstream bioprocessing equipment and operations for chromatography, protein purification, filtration technologies, formulation, 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 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:

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.

For jobs in the United States:

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 for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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