Manager - Outsourced Manufacturing, Biologics
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 15, 2021
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Job Description:
Manager - Outsourced Manufacturing, Biologics 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 Manager - Outsourced Manufacturing,
Biologics 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. This role will work
closely with process and analytical development teams to lead the
outsourcing of development, testing and manufacturing of multiple
clinical stage biologics at contract manufacturing organizations
and contract testing labs globally. Main Responsibilities: Actively
manage and oversee the outsourcing of analytical development,
testing, cell bank generation and bulk drug substance manufacturing
in partnership with analytical and process development and
biologics technical and manufacturing operations. Effectively
negotiate Confidentiality Agreements, Master Services Agreements
and Statements of Work Prepare, review and negotiate request for
proposals (RFP) and participate in due diligence evaluations of
CTLs and CMOs Act as a GSL (Gilead Site Lead) for High and Medium
level partners Responsible for purchase requisitions within
Gilead's accounting system (Oracle) Ensure accurate and on-time
invoicing and payments to Gilead partners Monitor and verify
implementation of Gilead's controlled documents at contract testing
labs (CTLs) and contract manufacturing sites globally Write, revise
and review Standard Operating Procedures Develop budgets and
accurately report accruals to Finance Support business reviews with
CTLs and external partners Effectively communicate issues to
management and project teams Participate in Operational Excellence
projects Job Functions and Duties: Organize and lead
teleconferences and face-to-face meetings with CTLs; work closely
with Gilead teams to manage deliverables Develop and maintain
outsourced project timelines and ensure progress against
established dates Onboard CTLs including integration into Gilead
systems Maintain oversight of financials and project deliverables
associated with outsourced development and testing activities
Proactively communicate issues, project changes to key stakeholders
and facilitate timely discussion and resolution Maintain project
documentation Knowledge, Experience and Skills : Prior experience
in biologics analytical testing, outsourced development and
contract manufacturing Specific knowledge of analytical and testing
requirements for biologic products for drug substance and drug
product. Strong computer skills and experience with an ERP system
and project management software Good understanding of activities
related to the CMC development and phasing of clinical stage
products Knowledge of GMPs and associated regulations (21CFR parts
11, 210, 211, 820) Ability to lead cross functional teams Strong
people management skills Strong negotiation, verbal and written
communication skills Ability to manage multiple programs/projects;
with sound organizational and time management skills Ability to
work in a highly dynamic environment and to resolve conflict in a
constructive manner Ability to solve 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 10% domestic and international
travel Minimum Experience and Education: 7 years of experience in a
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. Relocation package available for candidates outside of
the greater San Diego area 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 , Manager - Outsourced Manufacturing, Biologics, Executive , Oceanside, California
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