VP, Biologics Process Development
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 6, 2021
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Job Description:
VP, Biologics Process Development United States - California -
Oceanside Gilead Sciences, Inc. is a research-based
bio-pharmaceutical company that discovers, develops and
commercializes innovative medicines in areas of unmet medical need.
With each new discovery and investigational drug candidate, we seek
to improve the care of patients living with life-threatening
diseases around the world. Gilead---s therapeutic areas of focus
include HIV/AIDS, liver diseases, cancer and inflammation, and
serious respiratory and cardiovascular conditions. Making an impact
on a global scale Inclusion is one of the company---s five core
values. That---s because we know that we are stronger and more
innovative at Gilead when we are informed by a diverse set of
backgrounds, experiences and points of view. Gilead Sciences is a
biopharmaceutical company that discovers, develops and
commercializes innovative therapeutics in areas of unmet medical
need. The company's mission is to advance the care of patients
suffering from life-threatening diseases worldwide. When you join
Gilead, you join our mission to change the world by enabling people
to live healthier and more fulfilling lives. Come join a
mission-driven bio-pharmaceutical organization that values
inclusion and diversity, has a strong portfolio of products, and is
constantly CreatingPossible The Vice President, Biologics Process
Development will be responsible for overseeing the development of
biologic drug substance from research collaboration stage to
commercialization. The VP will provide leadership to an
organization responsible for Cell Line Development, Upstream
Process Development, Downstream Process Development,
Formulation/Drug Product Process Development, and Analytical
Operations including Quality Control. As the leader of all the
development functions for biologics, this position represents a
single point of CMC accountability for advancing Gilead's biologics
pipeline. In addition, the VP will be a member of the Biologics
Leadership Team, which is responsible for providing leadership and
decisions to the biologics development and commercialization
strategies and operation at the Oceanside site. Responsibilities:
Provide leadership and direction to the Biologics Process
Development organization, a department of > 100 scientists and
engineers Advance biologics candidates in pipeline by providing
overall CMC oversight, direction and decision. Provide strategic
directions to all biologics projects through interactions with each
biologics development (CMC) team Serve as a senior member of the
Biologics Leadership Team responsible for developing and
establishing biologics strategy and site operations Oversee
development operations for biologics projects, including mAbs,
recombinant proteins and therapeutic virus vaccines, from early
phase to commercialization Translating non-clinical and clinical
study demand of a new candidate biologics to development timelines
and manufacturing strategy for IND and BLA Develop and execute DS
and DP PPQ studies in alignment with Manufacturing and Technical
Operations Evaluate and implement new technologies to drive
innovation in biologics development, testing, and manufacturing
Drive development and implementation of new systems to improve
project execution and data management Lead collaborations with
Gilead biologics functions such as Quality Assurance, Manufacturing
and Technical Operations, Biologics Business Support Organization,
and Outsourcing Ensure strong relationships with Gilead
headquarters functions including Research, Clinical Development,
and Clinical Supply Management, by providing technical and
strategic input Form and guide biologics development (CMC) teams
consisting of representatives from each development function, in
order to drive and manage each biologic under development Hire,
mentor and develop team members within the organization Support
regulatory filings by guiding the draft, review, and approval of
CMC sections; support associated agency interactions and
product-related inspections Provide technical support to internal
and external cGMP manufacturing operations Develop and manage
department budget Qualifications: PhD in Chemical Engineering or
related disciplines 15 years of biopharmaceutical industry
experience with no less than 10 years of that experience focusing
on biologics manufacturing process development utilizing mammalian
cell lines Experience leading cross-functional biologics
development (CMC) teams consisting of representatives from multiple
functions such as Cell Line Development, Upstream Process
Development, Downstream Process Development, Formulation/Drug
Product Process Development, and Analytical Operations including
Quality Control Experience supporting multiple regulatory filings
including IND and BLA and supporting product-related inspections
for US and foreign regulatory agencies Experience developing,
implementing and executing strategic plans and objectives for
organizations and departments Experience working with external
manufacturing and testing organizations Experience with viral
vectors is a plus In-depth understanding of ICH guidelines and GMP
requirements for development and manufacturing of biologics Solid
understanding of current industry trends and regulatory
expectations associated with QbD, comparability evaluation, scale
up, and method and process validation Exceptional interaction,
leadership and command skills are required Leadership qualities of
the successful candidate include the following: collaboration,
building and developing high performing teams, accountability,
cross functional engagement and influence, program management,
strategic vision, executive presence. Gilead Core Values Integrity
(Doing What's Right) Inclusion (Encouraging Diversity) Teamwork
(Working Together) Excellence (Being Your Best) Accountability
(Taking Personal Responsibility) 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 careersgilead.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 careersgilead.com for assistance. For more
information about equal employment opportunity protections, please
view the ---EEO is the Law' 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.
Keywords: Gilead Sciences, Inc., Oceanside , VP, Biologics Process Development, Executive , Oceanside, California
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