Director, Biologics Analytical Operations
Director, 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. Gileads 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 companys five core values. Thats 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
Director, Biologics Analytical Operations (Phase Appropriate Analytical CMC Lead)
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
We are seeking a Director, for our 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 team.
- Coordinate and harmonize practices for early stage Analytical CMC approaches.
- Establish business practices, manage and lead the Analytical CMC team for late stage projects.
- Lead the analytical 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.
- Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trend 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.
Education, Experience and Skills:
- Ph.D. in Biological Sciences, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or relevant field with 12+ years of industry experience.
- Must have experience in leading a team to support of 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.
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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@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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