Director, Commercial Drug Product Technical Operations
United States - New Jersey - Morris PlainsUnited 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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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to apply for this job.Job DescriptionDirector, Commercial Drug Product Technical Operations
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 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.Role and Responsibilities:
The Commercial Biologics Technical Operations (CBTO) organization at Gilead is responsible for the technical oversight and support of commercial manufacturing across a global production network. We are accountable for direct technical support of drug substance, drug product and analytical operations, with responsibility for all aspects of process engineering: tech transfer, process validation, GMP manufacturing support, process monitoring and data analytics.
We are seeking a highly motivated individual with process development/manufacturing support experience to provide strong organizational, strategic and scientific leadership of the Commercial Drug Product Technical Operations organization. Primary responsibilities include developing the vision and strategy for the organization, ensuring timely completion of portfolio & functional deliverables as well as hiring & developing scientific talent. The successful candidate will establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success through tangible capability improvement. He/she will serve as a key link between commercial analytical function and other functional groups across the Biologics Operations organization at Gilead, to ensure seamless partnership and progress on organizational objectives. Experience with multiple modalities preferred, including hybrid molecules, ADCs, bispecifics. Essential Duties and Job Functions:
Specific Education & Experience:
- Manage multiple, complex long- term portfolio deliverables for late phase and commercial programs. Support manufacturing at various internal /external manufacturing sites to ensure flawless execution, on time release and delivery of product. Support investigations, change controls as needed. Work with development and tech transfer teams to ensure robust and reliable production processes are established, including lifecycle management of commercial products as well as new product introductions. Guide a highly diversified cross functional staff of professionals to ensure that all deliverables meet the highest scientific, regulatory, quality, and commercial standards.
- Define and implement phase-appropriate strategies, business processes, systems, and practices for efficient achievement of analytical deliverables in accordance with cGMP and ICH guidelines and industry best practices. Oversight of the commercial testing network ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing quality system requirements while leveraging robust risk management practices. Ensure compliance to safety, business policies, laws and regulations applicable to analytical operations. Work with teams to remove barriers to the successful advancement of the portfolio.
- Provide technical leadership to a team of process engineers, and scientists for new product introductions, and lifecycle management, including overseeing the design of studies, completion of investigations and writing/review of technical reports. Must stay current with relevant technologies and demonstrate forward thinking. Strong planning and resource management skills in a dynamic environment located across multiple geographies.
- Proactively develop and sustain strong relationships with internal/external stakeholders. Collaborate with Quality Control, Drug Substance/Drug Product Technical Operations, Quality Assurance, External Manufacturing, Regulatory CMC, Process Development, and other functional areas. Communicate across cross-functional / cross site teams to facilitate successful customer management and ensure timelines, deliverables, and business operations are aligned and met. Influence e stakeholders and communicate with senior leadership on issues, risks, and opportunities.
- Recruit, retain and develop high performing, empowered teams to execute organizational goals. Ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development, succession planning and routine rewards and recognitions practices.
- Represent CBTO during external and internal regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations.
- Champion innovation and continuous improvement. Aggressive growth and change management-oriented mindset aligned with the aspirations of the company. Establish and execute sound plans that enable Gilead's operational and strategic imperatives - both short term and long term. Lead development of dashboards to track, trend and report metrics. Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions with teams and executive management.
- Build resource and capacity utilization models for technical organization to provide an aggregated view. Use these models to inform and facilitate the organizational gaps and growth strategy discussions.
- Travel may be required in support of technology transfers to CMOs.
- 8+ years of relevant experience and a PhD in a relevant scientific discipline OR
- 10+ years of relevant experience and an MS in a relevant scientific discipline OR
- 12+ years of relevant experience and a BS in a relevant scientific discipline
- Strong understanding and extensive hands‐on experience in process development and/or MSAT. Deep understanding of product quality attributes control strategies as applied to biopharmaceutical processes. Sound background in large-scale processing and engineering fundamentals as applied to biopharmaceutical processes.
- Strong knowledge of cGMP requirements for clinical and commercial testing & manufacturing. In-depth knowledge of industry best practices & trends. Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings.
- Demonstrated leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a team of scientists to deliver on complex and challenging objectives in defined timelines. Ability to build teams where staff have a shared purpose and vision. Own the creation of a high performing team with a strong individual initiative, deep scientific curiosity, and natural environment of working together collaboratively. Coach and develop a strong pool of scientific talent.
- Demonstrated success working with diverse team members in a dynamic, cross‐ functional environment. Proactively identifies issues and provides solutions through solid problem solving skills. Confidence to lead through uncertainty in a rapidly changing, regulated environment.
- Motivated self starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation and scientific writing skills. Strong self-awareness of the impact communication and working style has on others. Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment. Demonstrated eminence in the scientific community.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/GileadAbout Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical 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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