Sr Associate Scientist - Microbiology Lead

Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: March 20, 2023

Job Description:

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 and verification/validations.
• 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 properly documented.
• 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