Sr Research Associate II Biologics Drug Product Development, Technical Operations
Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 15, 2023
Job Description:
Sr Research Associate II Biologics Drug Product Development,
Technical OperationsUnited States - California - OceansideGilead
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
scaleInclusion 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 For Current Gilead Employees and
Contractors:Please log onto your Internal Career Site to apply for
this job.Job DescriptionSr Research Associate II - Biologics Drug
Product Development, Technical 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.Gilead Sciences has an
opportunity for an experienced candidate in our Biologics Drug
Product Development Technical Operations group at our site in
Oceanside, CA. We are seeking motivated, team-oriented individuals
with scientific experience in process development and/or
manufacturing related to biologics.Essential Duties and Job
Functions:
- Understanding of drug product process development for early and
late stage biologics.
- Experience in supporting the tech transfer of parenteral,
biologics drug product processes to early phase and late phase
clinical manufacturing sites. Reviewing batch records and executing
technical operations business and quality processes
- May provide person-in-plant support during GMP manufacturing,
support ongoing manufacturing operations and release, as well as
assist in quality investigations as necessary.
- Trend manufacturing data and evaluating discrepancies
- May perform process development experiments, scale-down/-up
experiments to define drug product process parameters, and to
author protocols, summary reports, as well as sections of
regulatory submissions.
- Experience in lyophilized drug product process development,
mixing, filtration, and filling process unit operations.
- Has knowledge pertaining to global cGMP regulatory and guidance
documents, such as those from the FDA, EMEA, ICH, US/EU
Pharmacopeias, etc., related to drug product manufacturing.
- Be an effective communicator of ideas, project goals and
results in both written and presentation format. The candidate
should have the ability to proactively identify issues, make key
insights to data, and develop solutions in a collaborative
multidisciplinary environment.
- Candidates should be self-motivated, organized, thrive in team
settings and enjoy scientific investigation and thinking, as well
as be familiar with the relevant technical literature.Knowledge,
Experience and Skills:
- A minimum of 5+ years' industry experience with BS degree in
related scientific discipline or 3+ years' industry experience with
MS degree in related scientific discipline.
- Degree in Pharmaceutical Sciences, Chemical/Biochemical
Engineering, Biochemistry or a related scientific discipline and
relevant industry experience that demonstrates expertise in process
development or drug product technical operations as well as
sustained excellence in performance and accomplishments that align
to company goals.
- Excellent communication skills (both verbal and technical) and
interpersonal skills are required.
- Demonstrates technical proficiency, scientific creativity,
collaboration with others and independent thought in providing
manufacturing/process development approaches and troubleshooting.To
apply, please submit resume through our website at Gilead is an
equal opportunity employer.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 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' 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.
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Keywords: Gilead Sciences, Inc., Oceanside , Sr Research Associate II Biologics Drug Product Development, Technical Operations, IT / Software / Systems , Oceanside, California
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