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Executive Director, Vaccines External Development
2 months ago
We are seeking an esteemed leader in the external process development and manufacturing of vaccine drug substances (DS) as the Executive Director for External Development, based in West Point, PA.
This position will play a critical role in leading and coordinating key activities with strategic partners external to our company for vaccine development and manufacturing, life cycle management, and pandemic readiness, as well as driving operational excellence internally.
Our department Vaccines and Advanced Biotechnologies (VAX) Process R&D in Development Sciences & Clinical Supply (DSCS) is responsible for the development and clinical manufacturing of DS for the vaccine pipeline at our company, spanning from preclinical to commercialization stage.
We are part of the Process R&D organization, which enables modality-agnostic DS process development and clinical manufacturing for all of our company's pipeline.
The individual will report directly to the Associate Vice President of VAX Process R&D and will be expected to expertly represent the group on certain capacities, including but not limited to due diligence, regulatory input, and program leadership.
The role will also serve as a key mentor for the development of scientific and operational talents from a diverse background and advance our company's commitment to a diverse and inclusive work environment.
Primary Responsibilities:
- Strategic CMC Liaison with Hilleman Laboratories (an equaljoint venture between our company and British charitable foundation Wellcome Trust, named after the vaccine legend Dr. Maurice R Hilleman).
- Foster strong partnerships and facilitate collaboration to drive scientific advancements and global access of vaccines and drugs.
- CMC Lead for the next gen development for commercial vaccines through external collaborations.
- Lead CMC activities for the selected projects, which includes both clinical and commercial process development, technology transfer, manufacturing, and commercialization.
- Ensure effective coordination and execution of these activities to meet project timelines and objectives.
- CMC Liaison for Life Cycle Management (LCM) through external collaborations.
- Serve as the representative of DSCS for vaccine LCM projects to enable global access of vaccines.
- Work closely with the Clinical, Marketing, and Commercial Manufacturing team to identify LCM projects for vaccines that require external collaboration and externalization.
- From ideation to proposal and governance review, collaborate with internal and external stakeholders to drive the successful execution of these projects through external development.
- Collaborate with internal stakeholders in Discovery, Clinical, Commercial Manufacturing, Regulatory Affairs and Legal to develop a robust plan for pandemic/epidemic preparedness. This includes assessing and addressing potential risks, implementing mitigation strategies, and ensuring that the company is wellprepared to address such challenges from vaccine CMC perspective.
- Act as the CMC representative for external collaborations with government agencies and NGOs for pandemic/epidemic preparedness.
Operational Excellence Lead at VAX PR&D:
Leading operational excellence initiatives at the VAX PR&D organization.
- Align metrics, best practices, and standards across with other GMP pilot plants in PR&D to ensure Right First Time, efficient and compliant operations.
Education:
- Bachelor's Degree in microbiology, biochemistry, chemical engineering, or a relevant field.
Required Experience and Skills:
- A minimum of 20 years of leadership and managerial experience in vaccine CMC development, clinical GMP manufacturing, and commercial GMP manufacturing.
- Strong knowledge and expertise in vaccine development and CMC development, with a track record of leading Product Development teams and CMC development teams.
- Proven track record in strategic collaborations and international partnership management of vaccine development and GMP manufacturing for both DS and DP.
- Experience in pandemic/epidemic readiness planning and operation.
- Demonstrated ability to lead and drive operational excellence initiatives.
- Excellent communication, leadership, and influencing skills.
- Based in West Point, PA is required.
Preferred Experience and Skills:
- Extensive handson experience in vaccine process development, clinical and commercial manufacturing, as well as Quality oversight.
- Solid experience and proficient with major cell substrates (E. coli, yeasts, HEK293, Vero, CHO, etc) and modalities (LVV, viral vectors, RNA, protein subunits, conjugates, etc). Extensive experience in stateoftheart LVV development is desired.
- Strong knowledge of global regulatory, quality and manufacturing requirements for vaccines.
- Working knowledge on Drug Product Intermediates and adjuvant development and manufacturing.
- Experience in navigating complex governance processes and facilitating decisionmaking.
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