Assoc Director, External Manufacturing

Gilead Sciences, Inc.
Published
May 10, 2022
Location
Belmont, CA
Category
Job Type

Description

The Associate Director in Gilead's External Manufacturing organization will be responsible for managing device development and manufacturing at external partners, through close collaboration with our Device Development and Primary Packaging Engineering (DDCPE) Team.. This role will also include the management of parenteral drug product manufacturing at contract manufacturing organizations (CMOs) for clinical and/or commercial programs. We are seeking a high energy "go- getter" who will use their business savvy and technical experience to help drive high performance from our partners. You will have responsibility for leading cross-functional teams, bidding, selecting and managing multiple outsourced programs. This position will be eligible for Gilead's GFlex Program allowing remote work for up to three days a week.

We are seeking candidates with working experience collaborating with CMOs and/or device partners, with prior experience in clinical and/or commercial stages in an external manufacturing and/or business development setting. This individual will be a key point of contact between Gilead and one or more external partners, responsible for the overall supplier relationship.

Job Duties:

  • Manages external activities for parenteral drug product manufacturing and device development/manufacturing.
  • Serve as business lead and point of contact at external device partners and CMOs.
  • Collaborate with DDCPE to develop and refine strategy for management of device development/manufacturing, considering timelines, risk mitigation and business priorities.
  • Develops effective strategies for the evaluation and selection of device partners and CMOs.
  • Coordinates with legal, the technical and development teams and quality assurance/control groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements.
  • Reviews and facilitates approval of proposals, work orders, and changes of scope.
  • Collaborate with cross-functional team to lead transfer of new programs to various external partners.
  • Coordinate manufacturing schedules based on program requirements.
  • Monitors and troubleshoots key external activities via email, teleconferences, site visits and annual business review meetings.
  • Executes strategies that drive effective operational performance and service levels at external partners.
  • Communicates risks and delays to management and technical leads on a timely basis.
  • Resolves issues with external partners in a collaborative fashion, and escalate as needed.
  • Supports strategic business and quality compliance processes and changes by participating in working groups and acting as business process owner for system changes as needed.
  • Provides input for budgeting based on outsourced manufacturing needs.
  • Effectively communicate project, performance, and resource issues to management and within project teams.
  • Ability to travel domestically and internationally 5-10%.

Knowledge & Skills:

  • Able to influence and work well with others in a proactive and constructive manner.
  • Strong communication skills, both verbal and written, with all levels of an organization
  • An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements.
  • Proven ability to problem solve, build strong relationships, and to organize effectively.
  • Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions.
  • Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures.

Education and Experience:

  • A Bachelor's Degree and a minimum of ten (10) years of experience, OR a Master's Degree with a minimum of eight (8) years of experience.
  • Experience with primary packaging and/or device development and manufacturing, and parenteral drug product manufacturing for small molecules and/or biologics


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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 [Click Here to Email Your Resumé] for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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