Sr. Director, Biologics/Small Molecules Microbiology Quality Control

Gilead Sciences • Foster City, CA

291d • $243,100 - $314,600

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 fulfill their aspirations. Join Gilead and help create possible, together.

Requirements

• 15+ years' experience with a BS, OR 12+ years' experience with a MS OR 4+ Years with PhD in Microbiology, Chemistry, Biochemistry or related fields.
• 4+ years of relevant experience in a GMP Microbiology Lab environment.
• Knowledge of microbiological testing and experience with aseptic processing.
• Familiarity with microbiology laboratory instrumentation and environmental monitoring.
• Experience with GMP systems (e.g. LIMS, QMS, SAP) and software such as Empower, JMP, Discoverant.
• Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control.
• Prior senior leadership experience required.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills and collaborative interpersonal skills.

Responsibilities

• Lead the development and implementation of end-to-end Quality Control (QC) microbiological strategies for Gilead's biologics and small molecules products.
• Ensure that these strategies are effectively applied across all stages of the product clinical to commercial lifecycle.
• Provide leadership, guidance, and motivation to direct reports and project teams.
• Proactively manage daily internal and external business interactions with internal teams, CMO project leads, and management.
• Develop and implement innovative technologies, methods, and processes for microbial analysis.
• Ensure that all laboratory activities are conducted in compliance with relevant regulations and guidelines.
• Provide scientific leadership and technical expertise to the laboratory teams.
• Drive qualification, implementation and execution of micro USP methods for biological and small molecule products.
• Support microbiology quality events.
• Author and/or review microbiology procedures including protocols and reports.
• Manage sample submission to third party for microbial identification.
• Work closely with quality on defining and implementing aseptic techniques and cross contamination controls.
• Oversee the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting.
• Represent Gilead as Microbiology subject matter expert and interface with Regulatory agencies.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree