Quality Control Microbiologist III

Description

Essential Duties and Job Functions :

• Participate in analytical method transfers / method validations for Biological Products, as appropriate.
• Proficiently execute Molecular Bioassay techniques such as cell-based assays, ELISA, and receptor binding assays.
• Work with mammalian cell lines (Jurkat, PC-3, CHO) to determine biological activity of drug product by conducting cell binding assays, reporter assays, competitive binding assays, and cytotoxicity assays.

Conduct data analysis and evaluate the quality of data generated.

• Conduct data review of testing to ensure compliance with appropriate specifications and protocols.
• Develop subject matter expertise on assigned analytical techniques.
• Participate in deviations, investigations, and CAPAs, particularly in relation to laboratory testing and OOS results.
• Support troubleshooting of instrumentation and test methods within QC jurisdiction, as required.
• Support development, revision, and implementation of procedures to support laboratory testing.
• Write and execute protocols and reports.
• Support Quality Control functions and lab management.
• Coordinate waste management, LEAN, 6S, and continuous improvement efforts as required.
• Work on non-routine projects and assignments.
• Candidate should be self- motivated and organized.

Knowledge, Experience and Skills :

• Experience with GMPs, GLPs, pharmacopeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
• Experience with analytical techniques such as cell-based assays, ELISA, and receptor binding assays.
• Strong cell - culture experience and knowledge.
• Experience in method validation / method transfers is preferred.
• Experience with LIMS, ELN, LES, and Softmax Pro is preferred.
• Strong at time management.
• Ability and willingness to work flexible hours when needed.
• Ability to work in a fast-paced and highly collaborative working environment.
• Excellent written, verbal, and interpersonal communication skills.
• Excellent team player.

Typical Education & Experience

• 4+ years of relevant experience and a BSc, or 2+ years and an MSc in Biology, Biochemistry, or equivalent.
• Proficient in computer skills, including Microsoft Office (Word, Excel, PowerPoint) and others.
• Prior industry experience in a Biologics testing laboratory is preferred.

The salary range for this position is : $90,695.00 - $117,370.00. 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 :

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 for assistance.