Senior Director External Manufacturing, Biologics

Senior Director –External Manufacturing, Biologics- Oceanside, CA

The Senior Director in Gilead's External Manufacturing Organization will be responsible for effectively managing contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs) for biologics programs from research to commercial production. An ideal candidate is a highly motivated individual who will use their business acumen and technical knowledge to establish and sustain strong external relationships to drive high performance. The individual must be able to distill complex problems into concise and clear communication and content to enable effective decision making. Strong leadership is required to provide direction and develop teams either through direct management or matrixed relationships.

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 on-going 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.

Main Responsibilities:

• Manage external manufacturing and analytical testing of biologics programs
• Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
• Prepare, review and negotiate Request for Proposals (RFPs)
• Lead and participate in solving highly complex problems
• Provide input and recommendations on external investments
• Conduct and document risk assessments and develop appropriate mitigation strategies
• Coordinate and lead meetings with internal stakeholders and CMOs documenting discussion points and key decisions
• Develop budgets and accurately report accruals to Finance
• Lead/support business reviews for assigned external partners
• Ensure accurate and on-time payments to external partners
• Lead and participate in Operational Excellence projects
• Monitor and verify implementation of Gilead's controlled documents at CMOs and CTLs with Gilead's Contractor Manuals (CMs) system
• Write, revise and review Standard Operating Procedures
• Effectively manage people and teams directly and indirectly

Job Functions and Duties:

• Collaborate and maintain regular meetings with key stakeholders and external partners to ensure external needs are being met
• Evaluate, select and onboard CMOs/CTLs s including site visits, contract negotiation, initiating GMP audits, applicable Work Orders and Purchase Orders
• Maintain project timelines and evaluate progress against established deliverables
• Collaborate with key stakeholders to prioritize activities according to project needs
• Maintain oversight of financials and project deliverables associated with external development activities
• Organize and participate in teleconferences and face-to-face meetings with CMOs working closely with Gilead teams to establish agenda and keep track of key decisions
• Proactively communicate issues, project changes to key stakeholders and facilitates timely discussion and resolution
• Maintain and update documentation and timelines to accurately reflect the status of the external activities
• Function as people manager providing training and coaching, conducting performance assessments and developing meaningful development plans

Knowledge, Experience and Skills:

• 14+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be consider as 4 years' experience.
• Prior experience leading biologics external development and manufacturing
• Strong computer skills and experience with an ERP system and project management software
• Extensive understanding of activities related to the CMC development of biopharmaceuticals
• Advanced knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
• Ability to lead cross functional teams
• Strong people management skills
• Extensive experience negotiating complex agreements
• Strong verbal and written communication skills
• Ability to manage multiple programs/projects; sound organizational and time management skills is essential
• Ability to develop concise presentations to convey complex issues to senior management
• Ability to work under uncertainty and to resolve conflict in a constructive manner
• Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
• Ability to work in a fast-paced environment is essential
• Project management experience and/or certification are a plus
• This position may require up to 25% domestic and international travel

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 careers@gilead.com 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.​

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