Senior Associate Scientist — Quality Control Biologics (Clinical Analytical Operations)

About the position

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.

Responsibilities

• Provide support for strategic leadership and oversight of daily operations in Clinical Analytical Operations.
• Manage the release testing supporting Gilead’s Clinical biologics drug substances and drug products.
• Contribute to refining QC procedures across Gilead’s biologics manufacturing network.
• Ensure compliance with global cGMP and Gilead’s Quality Management System.

Requirements

• 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.
• Experience with Biologics Quality Control sub-functions and extensive knowledge of industry best practices and trends.
• Experience with or demonstrated capacity to learn GMP principles, concepts, practices and standards in the US and internationally.
• Ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
• Proven ability to work with senior management to develop and ensure support for Company-wide long-term solutions.
• Demonstrated ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gilead’s GMP policies.
• Demonstrated ability to influence process and outcomes across functions.

Nice-to-haves

• Experience in a Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation.
• Experience with GMP Systems such as LIMS, QMS, SAP.
• Experience with software such as JMP, Discoverant, Empower.
• Experience in Biopharmaceutical or Pharmaceutical quality control.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills and collaborative interpersonal skills.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.