Sr. Director, Biologics/Small Molecules Microbiology Quality Control

Description de l'emploi

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.

Senior Director — Biologics/Small Molecules Microbiology Quality Control

Foster City, CA

Key Responsibilities:

The QC Microbiology Senior Director is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides strategic leadership and oversee daily microbiological operations. Responsibilities include leading the microbiology QC team supporting both clinical and commercial programs for biologics and small molecule sectors. This individual is committed to personnel interactions (approachable) and mentoring of staff for timely project completion and regulatory compliance. The Senior Director collaborates with cross-functional teams, works with CTLs, and fosters a culture of continuous improvement.

Department

Global Quality Control – GQC-Biologics and Small Molecules

Job Responsibilities

• 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.

Qualifications

• 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, 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 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.