Sr. Manager, Commercial Biologics Analytical Operations
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 14, 2023
Job Description:
For Current Gilead Employees and Contractors:Please log onto
your Internal Career Site
(https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true)
to apply for this job.Job DescriptionSr. Manager, Commercial
Biologics Analytical OperationsGilead 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 ongoing 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.Roles and
Responsibilities:The Commercial Biologics Analytics Operations (AO)
organization at Gilead is responsible for the technical oversight
and commercial analytical support across a global production
network. This organization is accountable for all commercial
analytical operations, including method transfers, method
validations, method remediation's, method investigation support,
method life cycle management along with analytical support of drug
substance and drug product manufacturing. This organization is also
responsible for comparability, stability and specification setting
strategies as well as network and importation testing strategies
for all of Gileads marketed biologics products.We are seeking a
highly motivated individual with analytical development experience
to support the Commercial Biologics AO organization. Primary
responsibilities include ensuring timely completion of portfolio &
functional deliverables and serving as a key link between
commercial analytical function and other functional groups across
the Biologics Operations organization at Gilead, to ensure seamless
partnership and progress on organizational objectives. Experience
with multiple modalities preferred, including hybrid molecules,
ADCs, bispecifics.Essential Duties and Job Functions:
- Support multiple, complex long- term portfolio deliverables for
late phase and commercial programs, including method validations &
transfers, in process controls, reference standard & specification
strategies, comparability & stability strategies, importation
testing & network testing strategies. Support investigations change
controls as needed. Ensure that all deliverables meet the highest
scientific, regulatory, quality, and commercial standards.
- Support implementation of phase-appropriate strategies,
business processes, systems, and practices for efficient
achievement of analytical deliverables in accordance with cGMP and
ICH guidelines and industry best practices. Support the commercial
testing network ensuring effective information flow, timeline
execution, issue resolution, and documentation in accordance with
governing quality system requirements while leveraging robust risk
management practices.
- Provide technical support for new product introductions,
lifecycle management, investigations, troubleshooting and
writing/review of technical reports. Must stay current with
relevant technologies and demonstrate forward thinking. Strong
planning and resource management skills in a dynamic environment
located across multiple geographies.
- Review and summarize analytical data (including stability data)
from CTLs/CROs/CMOs, conduct trend analysis, provide feedback and
recommendation in assisting the timely resolution of technical
and/or quality issues.
- Maintain strong relationships with internal/external
stakeholders. Collaborate with Quality Control, Drug Substance/Drug
Product Technical Operations, Quality Assurance, External
Manufacturing and CTLs, Regulatory CMC, Process Development, and
other functional areas. Communicate across cross-functional / cross
site teams to facilitate ensure timelines, deliverables, and
business operations are aligned and met.
- Support Commercial Biologics AO during external and internal
regulatory inspections/audits. Participate in writing, reviewing
and approving CMC sections of US and international clinical trial
applications, regulatory question responses, supplemental biologics
license applications and international variations.
- Travel may be required in support of transfers/performance
management of CTLs.Specific Education & Experience:
- 4+ years of relevant experience and a PhD in a relevant
scientific discipline OR
- 6+ years of relevant experience and an MS in a relevant
scientific discipline OR
- 8+ years of relevant experience and a BS in a relevant
scientific disciplineSkills:
- Strong understanding and extensive handson experience in
analytical development, method transfers and method validations.
Deep understanding of product quality attributes control strategies
as applied to biopharmaceutical processes. Expert understanding and
hands-on experience of methods within the following platforms:
chromatography, capillary techniques, ELISA techniques, and
compendia assays supporting biologics manufacturing.
- Strong knowledge of cGMP requirements for clinical and
commercial testing & manufacturing, and experience working with
external manufacturing and testing organizations.
- In-depth knowledge of industry best practices & trends.
Familiarity in forensic investigations in support of manufacturing
of biologics. Familiarity with USP monographs and chapters, and
ICH/FDA guidance documents related to analytical operations. Proven
experience in the generation of relevant regulatory sections of
IND, BLA and MAA filings.
- Demonstrated success working with diverse team members in a
dynamic, cross functional environment. Proactively identifies
issues and provides solutions through solid problem-solving
skills.
- 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.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/GileadAbout Gilead:Gilead Sciences, Inc.
is a research-based biopharmaceutical 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. Gileads therapeutic
areas of focus include HIV/AIDS, liver diseases, cancer and
inflammation, and serious respiratory and cardiovascular
conditions.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., Canada, Australia,
Singapore, and Hong Kong 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.For more information about equal employment
opportunity protections, please view the 'Know Your Rights'
(https://www.eeoc.gov/employers/eeo-law-poster) poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT
(http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR
RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY
NONDISCRIMINATION PROVISION
(https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)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
(https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true)
to apply for this job.Gilead Sciences, Inc. is a biopharmaceutical
company that has pursued and achieved breakthroughs in medicine for
more than three decades, with the goal of creating a healthier
world for all people. The company is committed to advancing
innovative medicines to prevent and treat life-threatening
diseases, including HIV, viral hepatitis and cancer. Gilead
operates in more than 35 countries worldwide, with headquarters in
Foster City, California.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.,
Canada, Australia, Singapore, and Hong Kong employees and
contractors to be fully vaccinated against COVID-19 as a condition
of employment. T he health of our employees, contractors, their
loved ones, our partners and the communities and people we serve is
a top priority. Vaccination is the most effective way currently
available to deliver on that priority.The purpose of the
vaccination requirement is to minimize the spread of COVID-19 in
the workplace and support the health and safety of our communities.
A person is considered fully vaccinated two weeks after the second
dose of a two-dose vaccine or two weeks after 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
an accommodation.
Keywords: Gilead Sciences, Inc., Oceanside , Sr. Manager, Commercial Biologics Analytical Operations, Executive , Oceanside, California
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