Sr. Director, Biologics/Small Molecules Microbiology Quality Control

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 243,000 - 315,000; Full time

Job summary

An established industry player is seeking a Senior Director for Microbiology Quality Control to lead innovative strategies in biologics and small molecules. This pivotal role involves overseeing microbiology operations, mentoring a dedicated team, and ensuring compliance with regulatory standards. The ideal candidate will bring extensive experience in microbiological testing and a passion for fostering a culture of continuous improvement. Join a dynamic team committed to advancing life-saving therapies and making a significant impact on global health challenges. This is a unique opportunity to shape the future of quality control in a leading biopharmaceutical company.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• 15+ years of experience in microbiology with leadership roles.
• Strong background in GMP microbiology lab environments and testing.

Responsibilities

• Lead the development of QC microbiological strategies for products.
• Manage and mentor microbiology QC teams for project success.

Skills

Microbiological Testing

Aseptic Processing

Leadership

Critical Thinking

Communication Skills

Education

BS in Microbiology or related fields

MS in Microbiology or related fields

PhD in Microbiology or related fields

Tools

LIMS

QMS

SAP

Empower

JMP

Discoverant

Job description

Sr. Director, Biologics/Small Molecules Microbiology Quality Control

Sr. Director, Biologics/Small Molecules Microbiology Quality Control

locations United States - California - Foster City

time type Full time

posted on Vor 3 Tagen ausgeschrieben

job requisition id R0044811

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.

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 life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Key Responsibilities:

The QC Microbiology Senior Director is a vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides strategic leadership and oversees 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.

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 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.
• Ensure that all laboratory activities (internal and external) 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 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.

The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

About Us

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.