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Vaccine Process Development and Manufacturing Lead

Company: Gates foundation
Location: cambridge
Posted on: May 3, 2021

Job Description:

THE POSITIONReporting to the Vaccine Process Development and Manufacturing Leader, the Vaccine Process Development and Manufacturing Lead is responsible for developing physical products in the Gates MRI's vaccine pipeline. The MRI's focus is translation from discovery through late-stage development with a special emphasis on access and affordability of solutions to the poorest and most vulnerable. Therefore, our team's task is on one hand to accelerate the transition from candidate selection to First in Human studies and on the other hand to ensure that manufacturing efficiency and cost of goods are critical development goals. Specific focus will be on recombinant protein antigen vaccines and conjugate vaccines. Adjuvants also play an important role in the MRI's portfolio.This role will contribute to our mission through a range of activities from developability assessment through Drug Substance and Drug Product development, manufacturing for pre-clinical and early phase clinical studies, to establishing a commercially viable process and product design. The Gates MRI works in an outsourced model, so the Vaccine Process Development and Manufacturing Specialist will work with a network of trusted partners and manage activities through this network. Your ability to establish and maintain productive relationships will be a key part of your success and your opportunity in this role. With our goal of providing affordable solutions, innovation in manufacturing technology is not optional, it is key to our mission. This role will work with colleagues in the CMC department on implementation of innovative concepts and processes. The role calls for an individual who combines deep vaccine development expertise with the willingness to roll up their sleeves and address the issue of the day.Provides end to end CMC oversight to vaccine development programs consisting of analytical and formulation development, Drug Substance & Drug Product process development, scale-up, tech transfer, pre-clinical and clinical manufacturing, and commercial scale development.Works well within a network of trusted development and manufacturing partners.Oversees early phase analytical, formulation, process development and tech transfer to the CMO network.Manages Drug Substance and Drug Product manufacturing through the CMO network.Develops and implements solutions for accelerated candidate to first in human transitions.Directs commercial process development with a focus on access and affordability.Is a champion for implementation of innovative solutions.Authors CMC sections for regulatory filings.QUALIFICATIONSPhD degree in engineering or a scientific discipline.6 years of relevant industry experience in vaccine Drug Substance and Drug Product development, scale-up, and tech transfer. Adjuvant experience is a great plus. BS/MS candidates with extensive experience and demonstrated achievement in a similar environment also considered.Experience in CDMO/CMO management and oversight is essential.Early phase analytical and formulations experience.Good understanding of manufacturing efficiency and manufacturing cost structures.Good understanding of vaccine development and CMC's contribution to developability as a critical component of the Discovery to Development transition.Willingness to be both a program leader and a hands-on problem solver.Proven track record of strong collaboration with internal and external stakeholders.cGMP experience is a plus.Strong analytical and organizational skills.#LI-TH1As part of our standard hiring process for new employees, employment with the Bill & Melinda Gates Medical Research Institute will be contingent upon successful completion of a background check.The Bill & Melinda Gates Medical Research Institute is dedicated to the belief that all lives have equal value. We're committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve-in race, gender, age, cultures and beliefs-and we support this diversity through all of our employment practices.All applicants and employees who are drawn to serve the mission of the Bill & Melinda Gates Medical Research Institute will enjoy equality of opportunity and fair treatment without regard to:* Race* Color* Age* Religion* Pregnancy* Sex* Sexual Orientation* Disability* Gender Identity* Gender Expression* National Origin* Genetic Information* Veteran Status* Marital Status* Prior Protected Activity

Keywords: Gates foundation, Cambridge , Vaccine Process Development and Manufacturing Lead, Other , cambridge, Massachusetts

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