Principal Scientist, Quality Control Biologics (Microbiology)

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. 

Microbiology:

The QC Microbiology Principal Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control.  This individual provides support for strategic leadership and oversight of daily microbiological operations.  Responsibilities include managing clinical and commercial microbiological specification strategies (for product, raw materials and critical reagents programs), analytical method validations, and the compendial review program. 

The role will contribute to monitoring QC test method execution and leading the microbiological lifecycle management of clinical/commercial small molecules/biologics API/drug substances and drug products. 
 

Department:  

Global Quality Control – GQC-Biologics and Small Molecules 

Job Responsibilities:   

• Experience with Biologics and/or Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends. 

• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.  

• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.  

• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.  

• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.  

• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions. 

• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.  

• Demonstrated the ability to influence process and outcomes across functions. 

• Willing to support future laboratory work. 

Qualifications: 

• 10+ Years experience with BS OR

• 8+ Years with MS OR

• 5+ years of experience and PhD in Microbiology, Chemistry, Biochemistry or related field.  

• 2+ years of relevant experience in a GMP Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. 

• Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry. 

• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. 

• Strong organizational and planning skills. 

• Shows excellent verbal and written communication skills and collaborative interpersonal skills. 

The salary range for this position is: $182,070.00 - $235,620.00. 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.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.

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