Sr. Director, Biologics Drug Product MSAT

Sr. Director, Biologics Drug Product MSAT

Locations: United States - California - Foster City

Time Type: Full time

Posted on: More than 30 days ago

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.

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.

Role and Responsibilities:

• Directs the planning and execution of program strategy while considering process outputs, scalability, safety, sustainability, regulatory factors, and cost of goods.
• Manage multiple, complex long-term portfolio deliverables for late phase and commercial programs.
• Provide technical leadership to a team of process engineers and scientists for new product introductions and lifecycle management.
• Define and implement phase-appropriate strategies, business processes, systems, and practices for efficient achievement of deliverables in accordance with cGMP and ICH guidelines.
• Represent MSAT during external and internal regulatory inspections/audits.
• Proactively develop and sustain strong relationships with internal/external stakeholders.
• Manage direct reports, including subordinate managers with similar people and program responsibilities.
• Champion innovation and continuous improvement.
• Build resource and capacity utilization models for the technical organization.
• 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.
• Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing.
• Demonstrated leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a team.
• Demonstrated success working with diverse team members in a dynamic, cross‐functional environment.
• Motivated self-starter with excellent interpersonal and organizational skills.

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.

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. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.

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