47 applicants
Gilead Sciences · 2 days ago
Sr. Director, Biologics Drug Product MSAT
Foster City, CA
Full-time
Onsite
Director
$238K/yr - $308K/yr
12+ years exp
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Responsibilities
Direct the planning and execution of program strategy considering process outputs, scalability, safety, sustainability, regulatory factors, and cost of goods.
Lead teams through drug development and manufacturing, anticipate cross-functional challenges, and manage multiple complex long-term portfolio deliverables for late-phase and commercial programs.
Provide technical leadership for new product introductions, oversee the design of studies, tech transfers, completion of investigations, and writing/review of technical reports.
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.
Represent MSAT during external and internal regulatory inspections/audits, participate in writing, reviewing, and approving CMC sections of US and international clinical trial applications.
Develop and sustain strong relationships with internal/external stakeholders, collaborate with various functional areas, and communicate with senior leadership on issues, risks, and opportunities.
Manage direct reports, including subordinate managers, recruit, retain, and develop high-performing teams, and champion innovation and continuous improvement.
Build resource and capacity utilization models for the technical organization, facilitate root cause analysis, and lead development of dashboards to track, trend, and report metrics.
Qualification
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Required
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
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 testing & manufacturing. In-depth knowledge of industry best practices & trends. Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings.
Have a good understanding of regulatory requirements as well as the site requirements and procedures for a Biologics DP production facility, including cleaning validation and the processing equipment commissioning and qualification.
Demonstrated leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a team of scientists to deliver on complex and challenging objectives in defined timelines. Ability to build teams where staff have a shared purpose and vision. Own the creation of a high performing team with a strong individual initiative, deep scientific curiosity, and natural environment of working together collaboratively. Coach and develop a strong pool of scientific talent.
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. Strong self-awareness of the impact communication and working style has on others. Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment. Demonstrated eminence in the scientific community.
Preferred
Experience with multiple modalities preferred, including ADCs & bispecifics.
Benefits
Company-sponsored medical
Dental
Vision
Life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10,001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (163)
2022 (216)
2021 (218)
2020 (226)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
2017-10-27IPO· bit:GILD
Leadership Team
Patrick Loerch
Senior Vice President, Clinical Data Science
Ahmed Afifi
Vice President - Region Head Latin America
Recent News
http://www.zdnet.com/
2024-05-05
Company data provided by crunchbase
