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Director, Late-Phase Analytical CMC Lead, Biologics Analytical Operations

Employer
Gilead Sciences, Inc.
Location
Oceanside, CA
Start date
Mar 5, 2023

Job Details

Director, Late-Phase Analytical CMC Lead, Biologics Analytical Operations
United States - California - Oceanside

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


Director, Late Phase Analytical CMC Lead, Biologics Analytical Operations,

We are seeking a Director, for our late-phase Analytical Development team in Biologics Analytical Operations (BAO) team. Broad experience in analytical development from early development to commercial launch, filing experience with FDA/EMA, and in-depth technology understanding for biological products are the key in this role, which will expand our rapidly growing Oceanside, CA team. A solid understanding of GMPs and CMC requirements is expected.

Specific Responsibilities:
  • Lead the analytical development sub teams for late-stage development programs and coordinate technical aspects including but not limited to risk management, strategic planning and timeline management, in collaboration with the functional areas.
  • Contribute analytical CMC strategies and business practice to the analytical subteam and whole analytical organization
  • Lead integrated cross functional CMC subteams
  • Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trends into analytical development and control strategies.
  • Serve as an analytical representative on pharmaceutical development project teams and provides comprehensive project analysis to senior management.
  • Provide analytical oversight of the external testing site activities and work closely with CXO teams to ensure the timelines and deliverables including protocol/report review and approval, SOW and contract review.
  • Work with regulatory, QC, QA and senior management to ensure all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
  • Perform high level guidance for the analytical documents related to method development/validation, RS qualification, comparability studies, specifications, product characterization, CQA assessment, batch release and stability studies.
  • Design and execute the development plan to support global submissions.
  • Supervise or author analytical related regulatory dossiers and participate in the preparation of regulatory meetings if needed.
  • Support inspection readiness activities and associated health authority inspections.
  • Perform critical data review, design the relevant studies and provide directions for troubleshooting and investigation.
  • Support the outsourcing group for technical evaluations.
  • Work closely with the cross functional groups to achieve the project goals.

Experiences and Skills:
  • Must have experience in leading a team to support analytical development and process development.
  • Must have late stage development knowledge and BLA experience.
  • Broad and direct experience of managing a variety of analytical activities including method development and validation, reference standard, product characterization, comparability and CQA assessments.
  • Proven experience with managing CMO/CRO relationships and projects
  • Practical working knowledge of cGMP; capable of assessing compliance to quality requirements using sound judgment and risk management.
  • Must be familiar with ICH regulations and FDA/EMA requirements and expectations, plus experience with health authority inspections.
  • Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments.
  • Be self-motivated and organized, ability to prioritize multiple projects and excellent problem-solving skills.
  • Must think critically and creatively and be able to lead the late stage product development and filing.
  • Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.

Education:
  • Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with 12+ years of industry experience.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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 log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
US

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