Foster City, CA, 94404, USA
3 days ago
Executive Director, Global Biologics MSAT
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** **Executive Director, Global Biologics MSAT** The Global Biologics MSAT organization at Gilead is responsible for the technical oversight and support of clinical & commercial manufacturing across a global production network. The Executive Director will lead an organization that is 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 Global Biologics MSAT organization. Primary responsibilities include evolving 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. They will play an instrumental role in post-launch Life Cycle Management (LCM) and will be an integral member of the Pivotal/Commercial Biologics Technical Development Leadership Team. This leadership team oversees late-stage process development activities, including Cell Culture, Purification, Formulation & Process Development, Analytical Development, MSAT, and Materials Sciences. Experience with multiple modalities preferred, including ADCs & bispecifics. **Responsibilities:** + Provide leadership to the Global Biologics MSAT organization. + Manage multiple, complex long- term portfolio deliverables for late phase and commercial programs. Guide highly diversified, cross functional professionals to ensure that all deliverables meet the highest scientific, regulatory and quality standards. Work with teams to remove barriers to the successful advancement of the portfolio. 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. + Guide the draft, review, and approval of CMC sections in regulatory filings, and support agency interactions and inspections. + Proactively develop and sustain strong relationships with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC, Technical Development, Supply Chain, Finance to ensure timely delivery of late-stage/commercial portfolio. Foster robust relationships with PDM Product teams while providing technical and strategic input. Influence stakeholders and communicate with senior leadership on issues, risks, and opportunities. + 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. Strong planning and resource management skills in a dynamic environment located across multiple geographies. + Champion innovation and continuous improvement. Must stay current with relevant technologies and demonstrate forward thinking. 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. + Oversee departmental budgeting. Act as a key member of the Biologics Technical Development Leadership Team to shape late-stage Biologics strategy. **Qualifications:** + A Ph.D. or M.S. in a relevant field with 15+ years in process development/MSAT, showcasing increasing responsibility and comprehensive experience managing pipeline and lifecycle management programs. + 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 manufacturing. In-depth knowledge of industry best practices & trends. Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings. + Demonstrated leadership experience of progressively increased scope. Ability to inspire and lead a team of scientists to deliver on complex and challenging objectives in defined timelines, where staff have a shared purpose and vision. Develop high performing teams with a strong individual initiative and deep scientific curiosity + 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. Exceptional decision making, influencing, partnership, and collaboration skills and ability to drive results within a matrix environment. Demonstrated eminence in the scientific community. + Demonstrated strategic vision, executive presence and accountability **People Leader Accountabilities** : + Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams. + Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose. + Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. **Gilead Core Values** + Integrity (Doing What’s Right) + Inclusion (Encouraging Diversity) + Teamwork (Working Together) + Excellence (Being Your Best) + Accountability (Taking Personal Responsibility) 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. Gilead was 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. The salary range for this position is: $281,010.00 - $363,660.00. 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. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) 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 apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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