Sr Director BiologicsSmall Molecules Microbiology Quality Control

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

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Job Description

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 lifethreatening 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 crossfunctional teams works with CTLs and fosters a culture of continuous improvement.

Department

Global Quality Control GQCBiologicsand Small Molecules

Job Responsibilities

• Lead the development and implementation of endtoend Quality Control (QC) microbiological strategies for Gileads 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 microbiological 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 of micro USP methods for biological and small molecule product includes inprocess 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 daytoday 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.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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