Gilead Sciences, Inc.
Director, Biologics Drug Product MSAT
Gilead Sciences, Inc., Foster City, California, United States, 94420
Director, Biologics Drug Product MSAT
United States - California - Foster City
Process/Product Development & Operations
Regular Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together.Role and Responsibilities:The MSAT organization at Gilead is responsible for the technical oversight and support of commercial manufacturing across a global production network. We are accountable for direct technical support of drug substance and drug product operations, with responsibility for all aspects of process engineering: tech transfer, process validation, GMP manufacturing support, process monitoring and data analytics.We are seeking a highly motivated individual with process development/manufacturing support experience to provide strong organizational, strategic and scientific leadership of the Drug Product MSAT organization. Primary responsibilities include developing the vision and strategy for the organization, ensuring timely completion of portfolio & functional deliverables as well as hiring & developing scientific talent. The successful candidate will establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success through tangible capability improvement.Essential Duties and Job Functions:Directs the planning and execution of program strategy while considering process outputs, scalability, safety, sustainability, regulatory factors, and cost of goods. Leads teams through drug development and manufacturing with an ability to understand and anticipate cross-functional challenges.Manage multiple, complex long-term portfolio deliverables for late phase and commercial programs. Support manufacturing at various internal/external manufacturing sites to ensure flawless execution, on time release and delivery of product.Provide technical leadership to a team of process engineers and scientists for new product introductions and lifecycle management, including overseeing the design of studies, tech transfers completion of investigations and writing/review of technical reports.Define and implement phase-appropriate strategies, business processes, systems, and practices for efficient achievement of deliverables in accordance with cGMP and ICH guidelines & industry best practices.Represent MSAT during external and internal regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations.Proactively develop and sustain strong relationships with internal/external stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC, Process Development, Supply Chain and other functional areas.Manages direct reports, including subordinate managers with similar people and program responsibilities. Strong emphasis on developing colleagues, including mentorship to individuals and teams on science and strategy.Champion innovation and continuous improvement. Advises on scientific strategy and supports growth and development of innovation and technology.Build resource and capacity utilization models for technical organization to provide an aggregated view.Travel will be required for CMO oversight.Specific Education & Experience:8+ years of relevant experience and a PhD in a relevant scientific discipline
OR10+ years of relevant experience and a MS in relevant scientific discipline
OR12+ years of relevant experience and a BS in relevant scientific disciplineSkills:Strong understanding and extensive hands-on experience in process development and/or MSAT.Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing.Demonstrated leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a team of scientists to deliver on complex and challenging objectives in defined timelines.Excellent verbal communication, oral presentation and scientific writing skills.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/GileadThe salary range for this position is: $221,170.00 - $286,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.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.
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United States - California - Foster City
Process/Product Development & Operations
Regular Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Gilead and help create possible, together.Role and Responsibilities:The MSAT organization at Gilead is responsible for the technical oversight and support of commercial manufacturing across a global production network. We are accountable for direct technical support of drug substance and drug product operations, with responsibility for all aspects of process engineering: tech transfer, process validation, GMP manufacturing support, process monitoring and data analytics.We are seeking a highly motivated individual with process development/manufacturing support experience to provide strong organizational, strategic and scientific leadership of the Drug Product MSAT organization. Primary responsibilities include developing the vision and strategy for the organization, ensuring timely completion of portfolio & functional deliverables as well as hiring & developing scientific talent. The successful candidate will establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success through tangible capability improvement.Essential Duties and Job Functions:Directs the planning and execution of program strategy while considering process outputs, scalability, safety, sustainability, regulatory factors, and cost of goods. Leads teams through drug development and manufacturing with an ability to understand and anticipate cross-functional challenges.Manage multiple, complex long-term portfolio deliverables for late phase and commercial programs. Support manufacturing at various internal/external manufacturing sites to ensure flawless execution, on time release and delivery of product.Provide technical leadership to a team of process engineers and scientists for new product introductions and lifecycle management, including overseeing the design of studies, tech transfers completion of investigations and writing/review of technical reports.Define and implement phase-appropriate strategies, business processes, systems, and practices for efficient achievement of deliverables in accordance with cGMP and ICH guidelines & industry best practices.Represent MSAT during external and internal regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations.Proactively develop and sustain strong relationships with internal/external stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC, Process Development, Supply Chain and other functional areas.Manages direct reports, including subordinate managers with similar people and program responsibilities. Strong emphasis on developing colleagues, including mentorship to individuals and teams on science and strategy.Champion innovation and continuous improvement. Advises on scientific strategy and supports growth and development of innovation and technology.Build resource and capacity utilization models for technical organization to provide an aggregated view.Travel will be required for CMO oversight.Specific Education & Experience:8+ years of relevant experience and a PhD in a relevant scientific discipline
OR10+ years of relevant experience and a MS in relevant scientific discipline
OR12+ years of relevant experience and a BS in relevant scientific disciplineSkills:Strong understanding and extensive hands-on experience in process development and/or MSAT.Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing.Demonstrated leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a team of scientists to deliver on complex and challenging objectives in defined timelines.Excellent verbal communication, oral presentation and scientific writing skills.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/GileadThe salary range for this position is: $221,170.00 - $286,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.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.
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