Sr. Director, Biologics/Small Molecules Microbiology Quality Control

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

Job summary

An established industry player is seeking a dynamic Senior Director for Microbiology Quality Control. This pivotal role involves leading the QC microbiology team, developing innovative strategies for biologics and small molecules, and ensuring regulatory compliance. The ideal candidate will have extensive experience in microbiology and quality control, with a strong leadership background. Join a forward-thinking company dedicated to advancing life-saving therapies and fostering an inclusive environment where every employee can thrive. This is an exciting opportunity to make a significant impact in the biopharmaceutical industry.

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 a strong background in quality control.
• Experience in GMP microbiology lab environment with knowledge of microbiological testing.
• Strong leadership skills with a focus on developing teams and project management.

Responsibilities

• Lead the development of Quality Control microbiological strategies for product lifecycle.
• Provide leadership and guidance to QC teams, ensuring project timelines are met.
• Ensure compliance with regulations and provide scientific leadership to laboratory teams.

Skills

Microbiology

Quality Control

GMP Systems

Leadership

Regulatory Compliance

Analytical Skills

Communication Skills

Education

BS in Microbiology, Chemistry, or Biochemistry

MS in Microbiology, Chemistry, or Biochemistry

PhD in Microbiology, Chemistry, or Biochemistry

Tools

LIMS

QMS

SAP

Empower

JMP

Discoverant

Job description

Sr. Director, Biologics/Small Molecules Microbiology Quality Control

Join to apply for the Sr. Director, Biologics/Small Molecules Microbiology Quality Control role at Gilead Sciences

Sr. Director, Biologics/Small Molecules Microbiology Quality Control

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Join to apply for the Sr. Director, Biologics/Small Molecules Microbiology Quality Control role at Gilead Sciences

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.

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.
  
  

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 Additional Benefits Information, Visit

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] for assistance.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees And Contractors

Please apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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