Director, Quality Control Microbiology- Biologics​/Molecules

Job Description

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.

• Lead the development and implementation of end-to-end Quality Control (QC) microbiological strategies for Gilead’s biologics and small molecules products, including setting up specifications for e.g. cell banks, product, raw materials, environmental monitoring/facilities, etc. Ensure that these strategies are effectively applied across all stages of the product clinical to commercial lifecycle.

• Lead and Develop Teams. Provide leadership, guidance, and motivation to direct reports and project teams. Focus on developing strong leaders within the QC department, ensuring they are equipped to make critical decisions and meet project timelines.

• Proactively manage daily internal and external business which includes interactions with internal teams, CMO project leads, and management to plan, develop, and coordinate activities to set up/review/track and trend adventitious agent testing such as sterility, endotoxins, bioburden, micro-biological identification, particulate matter, and environmental monitoring.

• Develop and implement innovative technologies, methods, and processes for microbial analysis.

• Ensuring that all laboratory activities (internal and external) are conducted in compliance with relevant regulations and guidelines.

• Providing scientific leadership and technical expertise to the laboratory teams.

• Drive qualification, implementation and execution of micro USP methods for biological and small molecule product – includes in-process, release and stability.

• Support microbiology quality events.

• Author and/or review microbiology procedures including protocols and reports.

• Manage sample submission to third party for microbial identification.

• Manage and develop microbiology personnel and work closely with internal and external teams.

• Work closely with quality on defining and implementing aseptic techniques and cross contamination controls.

• Future management and oversight of the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting. Undertake facility environmental trend reporting.

• Work with accuracy, urgency and a continuous improvement perspective.

• Represent Gilead as Microbiology subject matter expert. Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to GxP.

• PhD with 8+ years of relevant experience in the pharmaceutical industry OR
• Master’s degree with 10+ years of relevant experience in the pharmaceutical industry OR
• Bachelor’s degree with 12+ years of experience in the pharmaceutical industry OR
• Associate’s degree with 14+ years of experience in the pharmaceutical industry OR
• High School Degree with 16+ years of experience in the pharmaceutical industry.

• 4+ 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.
• Must have 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. Stays ahead of shifting microbiological trends in industry.
• Prior senior leadership experience required.
• Must think critically…