Senior Associate Scientist, Quality Control- Microbiology (Small Molecule)

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
 

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

   

QC Microbiology: 

The QC Microbiology Senior Associate 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.  The role will contribute to monitoring QC test method execution and the microbiological lifecycle management.  

The role is accountable for refining QC procedures across Gilead’s small molecule and biologics manufacturing network, ensuring global cGMP compliance.  Responsibilities also include managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into Gilead’s LIMS.  
  

Department:   

Global Quality Control – GQC-Biologics and Small Molecules  

Job Responsibilities:    

• Experience with  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.  

Basic Qualifications:  

• Master's Degree in Chemistry, Biochemistry or related field and 3+ years of relevant experience OR 

• Bachelor's Degree in Chemistry, Biochemistry or related field and 5+ years of relevant experience OR 

• Associate’s Degree in Chemistry, Biochemistry or related field and 7+ years of relevant experience OR 

• High School Degree and 9+ years of relevant experience 

Preferred Qualifications: 

• Preferred 2+ years of relevant experience in a 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.