Sr Associate Scientist - Microbiology Manager

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Sr Associate Scientist - Microbiology Manager

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 active participation and leadership within high performing teams supporting biologics programs, clinical through commercialization. This role will have responsibility for internal and external Microbiological support through areas such as microbiological and viral testing oversight, contamination control related activities, in-process testing plans, method establishment/verification activities, product/process performance monitoring, establishment/revision of specifications, QC impacting change controls, regulatory filing support, and investigation oversight.

Essential Duties and Job Functions:

• Executes the goals of Quality Control function, ensuring high quality microbiological support for internal and external production, and microbiological contamination control programs, through collaboration with Manufacturing Operations, Manufacturing Sciences, Analytical Development, and Quality Assurance while ensuring compliance to cGMP's, and safety regulations.
• Leads and represents QC requirements on multiple projects, including oversight 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) authoring and/or review of relevant sections.
• 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 colleagues to create a lean culture.
• 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

• Knowledge of microbiological and viral testing requirements.

• Excellent communication skills (both verbal and technical) and interpersonal skills are 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.
• Knowledge and experience in manufacturing operations 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 experience.

The salary range for this position is: $117,725.00 - $152,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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.

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.

This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.