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.
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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

• Serve as an analytical representative on pharmaceutical development project teams and provides comprehensive project analysis to senior management.
• 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.
• 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.
• 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.
• Lead integrated cross functional CMC subteams
• Support the outsourcing group for technical evaluations.
• 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.
• Support inspection readiness activities and associated health authority inspections.
• Design and execute the development plan to support global submissions.
• Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trends into analytical development and control strategies.
• Supervise or author analytical related regulatory dossiers and participate in the preparation of regulatory meetings if needed.
• Contribute analytical CMC strategies and business practice to the analytical subteam and whole analytical organization
• Perform critical data review, design the relevant studies and provide directions for troubleshooting and investigation.
• Work closely with the cross functional groups to achieve the project goals.

Experiences And Skills

• Must have late stage development knowledge and BLA experience.
• Must have experience in leading a team to support analytical development and process development.
• Proven experience with managing CMO/CRO relationships and projects
• Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments.
• Must think critically and creatively and be able to lead the late stage product development and filing.
• Broad and direct experience of managing a variety of analytical activities including method development and validation, reference standard, product characterization, comparability and CQA assessments.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Be self-motivated and organized, ability to prioritize multiple projects and excellent problem-solving skills.
• 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.
• Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.

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 [email protected] for assistance.
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