Gilead Sciences Inc

Manager, Regulatory Affairs CMC

Gilead Sciences Inc • $133K — $172K *
Thousand Oaks, CA 91360In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree with 6 years of experience or Master's degree with 4 years of experience.
  • Experience with cell and gene therapy, particularly lentiviral vectors (LVV) and related manufacturing processes.
  • Familiarity with CMC regulatory requirements and ICH guidelines.
  • Proven track record in regulatory submissions and health authority interactions.
  • Strong organizational skills and attention to detail.
  • Effective communication skills, both written and verbal.

Responsibilities

  • Prepare and submit CMC regulatory filings, including INDs and BLAs.
  • Develop Module 3 (CMC) content in line with global regulatory norms for cell therapy products.
  • Execute global CMC regulatory strategies under senior guidance.
  • Collaborate cross-functionally to support regulatory deliverables related to LVV.
  • Manage health authority interactions and prepare documentation for inquiries.
  • Assess regulatory impacts of change controls in LVV processes.
  • Contribute to inspection readiness and maintain regulatory documentation.

Benefits

  • Flexible working policy with up to two remote workdays.
  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Annual discretionary bonuses and stock-based long-term incentives.
  • Potential for paid time off and other customizable benefits.
Full Job Description
Job Description

This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in Philadelphia PA, El Segundo, CA or Thousand Oaks, CA.

Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA or El Segundo, CA office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite
  • Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycle management.
  • Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements for cell therapy products and associated LVV and critical raw materials.
  • Assist in execution of global CMC regulatory strategies under guidance of senior staff for both cell therapy products and lentiviral vector manufacturing platforms.
  • Partner with related to LVV process development, manufacturing, analytical testing, comparability, and supply continuity cross-functional teams (e.g., Process Design, MSAT, Quality, Manufacturing, Supply Chain) to support regulatory deliverables
  • Support health authority interactions, including preparation of responses to information requests (IRs/RTQs) and meeting materials related to LVV manufacturing processes, control strategy, potency, safety testing, and process validation
  • Assess change controls for regulatory impact and support lifecycle management activities including changes associated with LVV manufacturing processes, raw materials, analytical methods, manufacturing sites, and production scale.
  • Support activities related to manufacturing changes, comparability, and site updates or both cell therapy and LVV manufacturing operations.
  • Contribute to inspection readiness activities, including preparation of supporting documentation for LVV and cell therapy manufacturing facilities.
  • Maintain accurate regulatory records and documentation in relevant systems related to LVV manufacturing, supply, regulatory compliance, and health authority commitments
  • Identify and escalate risks and contribute to mitigation strategies focused on evolving global regulatory expectations for gene-modified cell therapies and viral vectors
  • Participate in continuous improvement initiatives and knowledge-sharing activities


Knowledge, Skills, and Abilities
  • Foundational knowledge of CMC regulatory requirements and ICH guidelines
  • Strong written and verbal communication skills
  • Attention to detail and strong organizational skills
  • Ability to manage multiple priorities in a fast-paced environment
  • Effective cross-functional collaboration
  • Proactive and solution-oriented mindset


Core Competencies
  • Working knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), and analytical characterization approaches.
  • Understanding of regulatory expectations for viral vector comparability, process validation, control strategy development, and post-approval lifecycle management.
  • Knowledge of global regulatory requirements and emerging guidance applicable to cell and gene therapy products, including viral vector starting materials.
  • Ability to assess manufacturing changes and interpret their potential regulatory impact on LVV quality, safety, potency, and supply continuity


Scope and Impact
  • Supports regulatory activities for assigned programs under guidance
  • Contributes to timely delivery of regulatory submissions and responses
  • Builds foundational expertise in Regulatory CMC
  • Supports development and execution of regulatory strategies for lentiviral vector manufacturing processes used in commercial and late-stage clinical cell therapy programs.
  • Contributes to regulatory assessments and risk management activities associated with LVV manufacturing changes, facility transfers, process improvements, and capacity expansion initiatives.


Basic Qualifications

Bachelor's degree with Six Years' experience

OR

Master's degree with Fours Years' experience

Preferred Qualifications
  • Degree in a scientific discipline
  • Experience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control strategies, and lifecycle management
  • Experience supporting regulatory submissions and health authority interactions
  • Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization.
  • Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management


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.


The salary range for this position is: $133,195.00 - $172,370.00. Kite 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.

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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