Hiring company: Gilead
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: 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.