Gates Medical Research Institute
Job Title: Biologics Process Development & Manufacturing Lead
Job Number: 30701
Location: Cambridge, MA
Reporting to the Biologics Process Development and Manufacturing Leader, the Biologics Process Development and Manufacturing Lead is responsible for developing physical products in the Gates MRI’s Biologics 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 commercially viable manufacturing approaches development at the right time. A specific focus of this role will be on Biologics drug substance upstream aspects, for pipeline projects from pre-candidate selection through commercial process definition.
This role will contribute to our mission through a range of activities from developability assessment through Drug Substance 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 Biologics Process Development and Manufacturing lead 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 required, it is the 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 Biologics development expertise with the willingness to roll up their sleeves and address the issue of the day.
- Provides end to end CMC oversight to Biologics development programs consisting of drug substance process development, analytical and formulation 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 manufacturing through the CMO network.
- Develops and implements solutions for accelerated candidate to first in human transitions.
- Directs subsequent clinical and commercial process development with a focus on access and affordability.
- Is a champion for implementation of innovative solutions.
- Authors CMC sections for regulatory filings.
- In collaboration with Quality Assurance, reviews and approves clinical materials for use.
- Represents the CMC function on project teams and/or project sub-teams.
- PhD degree in discipline Chemistry, Chemical Engineering, Biologics Sciences or equivalent.
- 10+ years of relevant industry experience in Biologics cell line development and drug substance upstream development, scale-up, and tech transfer, with a specific focus on cell line development and cell culture development. 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- and late-phase analytical and formulations experience.
- Good understanding of manufacturing efficiency and manufacturing cost structures.
- Good understanding of Biologics 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.
- Strong analytical and organizational skills.
The Gates MRI requires all employees based in the United States to provide proof of full vaccination against COVID-19, subject to applicable laws