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Vice President, Clinical Manufacturing

2 months ago

San Mateo, United States Gilead Sciences Full time

Vice President, Clinical Manufacturing page is loaded

Vice President, Clinical Manufacturing Apply locations United States - California - Foster City time type Full time posted on Posted 7 Days Ago job requisition id R0041567 For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

The Vice President of clinical manufacturing is a vital partner for the success of clinical manufacturing. The VP provides thought partnership for our partners through strategic leadership, networking and daily operations in the Foster City clinical manufacturing site. This role provides a unique opportunity for a leader to join and partner in the development of a greenfield project that will quickly evolve to our first biologic manufacturing site located in Foster City. Critical to the success of this role will be the leaders ability to network and partner and build manufacturings reputation as the partner everyone wants to work with and is a model of Gileads leadership commitments.

The role is accountable for the most diverse manufacturing site with small molecule clinical drug substance, oral drug product and biological drug substance manufacturing. Accountabilities include cGMP manufacturing team, managing production logistics, safety, quality and compliance of clinical manufacturing.

Job Responsibilities:

  • Partner in the development and build out of the Foster City location.

  • Develops medium and long-term strategic objectives for the clinical manufacturing and leads the management team in the development and implementation of operational plans. Communicates and creates buy in for the business plans and vision for the future to ensure strategic goals are achieved.

  • Partner with other functions to champion and implement technology innovation.

  • Maintain right to operate and highest safety standards.

  • Provide leadership to direct reports and build a highly capable team through the attraction, training, and development of the necessary skilled professionals to meet short- and long-term business needs. Anticipates shifts in industry trends and regulatory environment that will impact Gileads business needs and positions the function to respond accordingly.

  • Determines operational headcount projections with his/her senior management team. Manages, coaches and develops staff. Undertakes periodical and regular meetings with direct reports and contributes to establishing goals and objectives.

  • Partner on capital projects with Technical Development, Quality Assurance and Corporate Engineering to ensure on time and on budget delivery of new manufacturing capabilities.

  • Leads the development of the site manufacturing budgets in collaboration with departmental heads and guidance from the head of global manufacturing. Manages expenses in accordance with the approved budget. Maintains a detailed budgetary analysis and acts upon budget deviations.

  • Closely work with Technical Development to ensure rapid bench to plant execution of safe, flexible and compliant clinical manufacturing.

  • Coordinate internal site tech transfers from pilot scale to commercial scale production for small molecule drug substances, biological drug substances and oral drug products.

Requirements:

  • Experienced understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and solid knowledge of worldwide regulatory requirements.

  • Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills.

  • Demonstrated success in developing a strategy that delivered results.

  • Expertise and track record in managing manufacturing quality in a large, global pharma company.

  • Expert people and project management skills.

  • Possesses in-depth knowledge of industry best practices.

  • Strong working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH guidance.

  • Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.

  • Prior success in working effectively with senior scientific and operations staff.

  • Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.

Qualifications:

  • 20+ years of experience and a BS, or degree in Chemistry, Biochemistry, Chemical Engineering or related disciplines.

  • An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.

  • Experience leading a biologic or a small molecule manufacturing team.

  • Experience in regulatory filings including IND and BLA/NDA and post-marketing submissions.

  • Experience working with internal and external manufacturing organizations.

  • In-depth understanding of ICH guidelines and GMP requirements.

  • Solid understanding of current industry trends and regulatory expectations associated with pharmaceutical manufacturing areas, including new technologies, and approaches.

  • Exceptional interaction, leadership and communication skills are required.

  • Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision.

Gilead Core Values

Integrity (Doing Whats Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 careers@gilead.com for assistance.


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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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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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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