Sr Associate Scientist - Microbiology Lead
Company: Gilead Sciences, Inc.
Posted on: March 20, 2023
For Current Gilead Employees and Contractors:Please log onto
your to apply for this job.Job DescriptionQC PDM Sr Associate
Scientist - Microbiology Lead The successful candidate will possess
a strong understanding of Quality Control Microbiology in support
of large molecule manufacturing. The candidate must be highly
motivated to contribute to the development of biologics targeting
unmet medical need through the establishment and leadership of a
high performing teams and programs supporting biologics programs,
clinical through commercialization. - This role will have
responsibility for internal and external Microbiological support
through areas such as contamination control strategies, in-process
testing plans, method establishment/validation activities,
product/process performance monitoring, establishment/revision of
specifications, QC impacting change controls, and investigation
oversight.Essential Duties and Job Functions:
- Executes the Quality Control product quality function, ensuring
processes provide high quality microbiological support for internal
and external production, microbiological contamination control
strategies and programs, through collaboration with manufacturing
operations and analytical development while ensuring compliance to
cGMP's, and safety regulations.
- Leads and represents QC requirements on multiple projects,
including design and implementation of microbiological study design
- Owns and directs efforts in support of Quality Systems records,
deviations, CAPAs, and change controls.
- Supports regulatory filings (IND/IMPD/BLA/MAA) through
authoring and/or review
- Works with Regulatory & Quality Assurance to ensure that all
procedures and applicable regulatory requirements are followed and
- Must think critically and creatively and be able to work
independently, determine appropriate resources for resolution of
problems, and have strong organizational and planning skills.
- Must be able to analyze process, lead improvement activities,
and empower staff to create a lean culture in the laboratory.
- Will work on more complex problems where analysis of situations
or data requires in-depth evaluation of various factors, strong
judgment is required in resolving problems and making
recommendations - typically high impact issues that have
implications across functions.
- Demonstrated ability to execute against the strategic and
tactical objectives provided by senior leaders both within Quality
Control and outside of the function.
- Demonstrated ability in integrating varied concepts and data to
develop relevant solutions
- Demonstrated ability to successfully interact with other
functions on projects that involve negotiation and collaboration
with cross-functional peers and more senior management levels.
- Supports and/or coordinates internal and external regulatory
audits as required.Knowledge, Experience and Skills
- Excellent communication skills (both verbal and technical) and
interpersonal skills are required.
- Demonstrated people management skills required
- In-depth knowledge of Good Manufacturing Practices (GMPs)
and/or Good Laboratory Practices (GLPs)
- In-depth knowledge of QC principles, concepts, industry
practices, and standards
- Keen understanding of international quality control systems
regulations to adopt best in class systems/processes and drive
continuous improvement initiatives.
- Knowledge and experience in Quality Control in a highly
regulated manufacturing environments is preferred.
- Knowledge and experience in Quality Control oversite of CXO
organizations is highly desirable.Basic Qualifications
- Bachelor's or master's degree in microbiology, analytical
chemistry, biochemistry, pharmacology or a related discipline from
an accredited university.
- Bachelor's degree will possess 6+ years of relevant
biotech/pharmaceutical professional experience.
- Master's degree will possess 4+ relevant biotech/pharmaceutical
professional experienceFor 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 - poster.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 to
apply for this job.
Keywords: Gilead Sciences, Inc., Oceanside , Sr Associate Scientist - Microbiology Lead, Other , Oceanside, California
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