Sr. Director, Biologics Drug Product MSAT

Sr. Director, Biologics Drug Product MSAT
United States - California - Foster City
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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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 fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Senior Director, Biologics Drug Product MSAT
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 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. He/she will serve as a key link between the Drug Product MSAT function and other functional groups across the Technical Development organization at Gilead, to ensure seamless partnership and progress on organizational objectives. Experience with multiple modalities preferred, including ADCs & bispecifics.
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. Support investigations & change controls as needed. Work with development to ensure robust and reliable production processes are established, including lifecycle management of commercial products. Guide highly diversified, cross functional professionals to ensure that all deliverables meet the highest scientific, regulatory and quality standards.

• 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. Must stay current with relevant technologies and demonstrate forward thinking. Strong planning and resource management skills in a dynamic environment located across multiple geographies.

• 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. Oversee the commercial manufacturing network ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing quality system requirements while leveraging robust risk management practices. Ensure compliance to safety, business policies, laws and regulations applicable to Drug Product operations. Work with teams to remove barriers to the successful advancement of the portfolio.

• 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. Communicate across cross-functional / cross site teams to facilitate successful customer management and ensure timelines, deliverables, and business operations are aligned and met. Influence stakeholders and communicate with senior leadership on issues, risks, and opportunities.
• 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 with influence beyond one's own group members and programs. Recruit, retain and develop high performing, empowered teams to execute organizational goals. Ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development, succession planning and routine rewards and recognitions practices.

• Champion innovation and continuous improvement. Advises on scientific strategy and supports growth and development of innovation and technology. Leads and/or participates in initiatives to improve organizational governance and workflow. Aggressive growth and change management-oriented mindset aligned with the aspirations of the company. Establish and execute sound plans that enable Gilead's operational and strategic imperatives - both short term and long term. Lead development of dashboards to track, trend and report metrics. Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions with teams and executive management.
• Build resource and capacity utilization models for technical organization to provide an aggregated view. Use these models to inform and facilitate the organizational gaps and growth strategy discussions.

• Travel will be required for CMO oversight.

Specific Education & Experience:

• 12+ years of relevant experience and a PhD in a relevant scientific discipline OR 12+ years of experience and a MS in a relevant scientific discipline OR 14+ years of relevant experience and a BS degree in a relevant scientific discipline

Skills:

• Strong understanding and extensive hands‐on experience in process development and/or MSAT. Deep understanding of product quality attributes control strategies as applied to biopharmaceutical processes. Sound background in large-scale processing and engineering fundamentals as applied to biopharmaceutical processes.
• Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing. In-depth knowledge of industry best practices & trends. Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings.
• Have a good understanding of regulatory requirements as well as the site requirements and procedures for a Biologics DP production facility, including cleaning validation and the processing equipment commissioning and qualification.
• 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. Ability to build teams where staff have a shared purpose and vision. Own the creation of a high performing team with a strong individual initiative, deep scientific curiosity, and natural environment of working together collaboratively. Coach and develop a strong pool of scientific talent.
• Demonstrated success working with diverse team members in a dynamic, cross‐ functional environment. Proactively identifies issues and provides solutions through solid problem solving skills. Confidence to lead through uncertainty in a rapidly changing, regulated environment.
• Motivated self starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation and scientific writing skills. Strong self-awareness of the impact communication and working style has on others. Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment. Demonstrated eminence in the scientific community.

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.
The salary range for this position is: $237,660.00 - $307,560.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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 ApplicantAccommodations@gilead.com for assistance.
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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:
Please log onto your Internal Career Site to apply for this job.
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