Gilead Sciences Inc

Principal Scientist, Analytical Operations

Gilead Sciences Inc • $100K — $130K *
Edmonton, AB T5A 0A1In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • PhD in chemistry or related area with 5+ years of experience, or MA/MS with 8+ years, or BA with 10+ years.
  • Hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control (10+ years preferred).
  • Prior experience in establishing analytical specifications and authoring CMC sections of regulatory submissions.
  • Strong knowledge of cGMP principles and phase-appropriate QC expectations for clinical development.
  • Demonstrated experience managing testing at external laboratories and contract manufacturing organizations.

Responsibilities

  • Define and implement QC strategy for small molecule clinical programs.
  • Serve as primary contact for QC activities including method validation and cGMP release testing.
  • Develop phase-appropriate QC processes for manufacturing and regulatory submissions.
  • Manage and approve specifications in collaboration with cross-functional teams.
  • Represent QC on product development teams, providing technical direction and inputs.
  • Drive opportunities for improvement in QC workflows and compliance processes.
  • Proactively identify and escalate QC risks to stakeholders.

Benefits

  • Comprehensive medical, dental, and vision plans.
  • 401(k) retirement plan with company match.
  • Generous paid time off policy.
  • Support for professional development and ongoing education.
  • Flexible work arrangements to balance work and personal life.
Full Job Description
Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Principal Scientist, Analytical Operations, you will assume a full-time employment role within Global Quality's Commercial Analytical Support group.

The Principal Scientist will primarily assume a Quality Control (QC) lead role and will be responsible for the strategic oversight and operational execution of cGMP analytical testing in support of small molecule clinical development programs.

The role provides leadership for assigned programs across a range of QC activities, ensuring that testing, documentation, and data integrity standards meet regulatory requirements and project deliverables. The ideal candidate will bring deep technical expertise in analytical chemistry and cGMP operations, a strong understanding of phase-appropriate quality control strategies and requirements, and the ability to collaborate cross-functionally to enable successful delivery of clinical supply and development milestones.

This position will also involve leading cGMP analytical aspects of commercial small molecule APIs by managing analytical technology transfer activities to contract manufacturing organizations (CMOs), analytical support of commercial manufacturing at CMOs, and supporting regulatory activities (inspection readiness and support, regulatory responses, etc.).

Quality Control Leadership & Strategy
  • Define, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives.
  • Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories.
  • Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissions
  • Responsible for the management and approval of specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations
  • Represent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions.
  • Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes.
  • Proactively identify and escalate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders


Analytical Testing & Documentation
  • Oversee and ensure compliant execution of QC testing for raw materials, in-process, intermediates, drug substance, and drug product
  • Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records
  • Provide QC oversight to contract manufacturing organizations and testing laboratories, coordinating testing activities for on-time delivery and confirming compliance with cGMP and data integrity expectations
  • Direct and oversee timely resolution of QC testing related investigations with comprehensive root-cause analysis, risk assessment, and effective CAPAs
  • Advises members of project teams in the initiation and execution of GMP activities


Compliance & Regulatory Affairs
  • Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable
  • Drive excellence in data integrity, documentation practices, and traceability across QC
  • Serve as a QC subject matter expert to draft and review CMC sections and supporting documents for regulatory filings and response to questions (RTQs).


Cross-Functional Collaboration
  • Partner closely with Analytical Development, Manufacturing (Global External Manufacturing, Manufacturing Science and Technology), Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycle
  • Support technology transfer and method implementation at internal and external laboratories
  • Provide QC input into product development and regulatory submission documentation


Requirements
  • PhD in chemistry or related area and 5+ years of relevant experience OR
  • MA/MS in chemistry or related area with 8+ years of relevant experience OR
  • BA in chemistry or related area with 10+ years of relevant experience


Preferred Qualifications
  • 10 + years of hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control.
  • Prior experience establishing analytical specifications and authoring CMC sections of regulatory submissions.
  • Strong understanding and application of cGMP principles, concepts, practices and standards
  • Deep understanding of regulatory and phase-appropriate QC expectations for clinical development.
  • Demonstrated experience managing testing activities at external testing laboratories and contract manufacturing organizations.
  • Excellent scientific judgement, communication, cross-functional collaboration, and influencing skills.
  • Demonstrated ability to organize, plan, and execute multiple tasks with flexibility for changing priorities and plans.
  • Must think critically and creatively and be able to work independently to determine appropriate strategies and resources for resolution of problems
  • Knowledge of medical devices and combination products


People Leader Accountabilities
  • Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
  • Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.


For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

Grow Your Career

Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

Be Part of Our Team

Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

Explore Jobs at Gilead Sciences Inc

Discover the exciting career opportunities waiting for you at Gilead Sciences Inc. Visit our careers page to search for open positions, read about our company culture, and learn how you can make a difference in the global healthcare landscape.

Stay Up to Date

Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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