Sr. Director – Quality Control, Biologics Analytical Operations, Morris Plains, NJ
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.
The Sr. Director QC role is part of our Pharmaceutical Development and Manufacturing organization that has a diverse workforce in 11 countries. PDM is responsible for all development and manufacturing activities encompassing process and device development, production, analytical operations, information systems, quality assurance and regulatory affairs, as well as supply chain management for all of Gilead’s small molecules, biologics and antibody-drug conjugates in development programs and commercial products. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
- Ensure the success of the Biologics Analytical Operations Quality Control through strategic and day to day leadership.
- Leadership of NJ site QC analytical operations to execute QC and Microbiological testing in support of site clinical and commercial monoclonal antibody operations.
- Accountable for data review and first line troubleshooting of analytical testing across external network partners for Biologics portfolio.
- Define and execute on continuous improvement opportunities for site QC/Micro laboratories to drive efficiencies in operations.
- Support validation of Gilead analytical methods for new Biologics programs and transfer of methods to outsourced partners to ensure that the GMP testing needs of the Gilead Biologics are met.
- In all work utilize a thorough understanding of the phase appropriate global cGMP regulations and expectations surrounding the release and stability testing of biologic products.
- Demonstrate a clear understanding of the methods and assays used in biological product testing to enable prompt and effective transfers and troubleshooting of methods and reconciliation of atypical results.
- Work closely with partner organizations for the identification and selection of contract manufacturing and testing organizations, to ensure Gilead sponsored programs are manufactured and tested to ensure product quality. Establish clear expectations, metrics and KPIs, as appropriate to monitor analytical method performance.
- Provide coaching, guidance and career development to a highly motivated and very competent QC team.
- Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
- Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
- Lead, motivate, and develop the people in their group.
- Routinely make decisions affecting direction of project to ensure project timelines are met.
- Direct QC staff members of project teams (as needed) in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Knowledge, Experience and Skills:
- PhD in a relevant scientific discipline with ≥ 15 years of industry experience is required or MS Degree or BS Degree extensive industry experience; with a background in Chemistry, Analytical Chemistry, Biochemistry, or Biology
- Experience with leading and managing large teams is required
- Experience with analytical method validation and optimization for Biologics drug substance/drug product release and stability testing is required
- Experience with applying the principles and techniques of Analytical Chemistry is required
- Extensive experience and knowledge of GMPs is required
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