Associate Director/Director of Biologics CMC

Job Details

Location:
New York, NY
Department:
Research & Development
Posted Date:
June 29, 2021

Job Summary

At Roivant, we are passionate about discovering and developing new drugs to impact patients' lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world's leading tech-enabled pharmaceutical company.

Roivant's drug discovery capabilities are driven by our computational discovery platform, which combines preeminent physics-based tools with deep expertise in machine learning to generate unprecedented analytical power that can tackle previously intractable discovery challenges. The tight integration of this computational platform with our experimental capabilities enables the rapid design and optimization of new drugs to address a wide range of targets for diseases with high unmet need.

We believe that the future of drug discovery lies in integrating predictive sciences, biology and medicinal chemistry to accelerate the path to new medicines. This role is an opportunity to be an architect of this paradigm shift and generate transformative benefit for patients

Position Summary

The Director of CMC Biologics will be responsible for providing CMC leadership and technical management for clinical development programs. Activities include management of process development, which includes oversight of upstream and downstream process development and drug product development conducted at CROs/CDMOs, technology transfer, and manufacturing,. They will provide technical leadership regarding CMC strategy and global regulatory submissions.  In cooperation with the project team, they will direct the CMC program budget and timelines to deliver the company's CMC development programs on schedule.

Responsibilities 

  • Lead CMC aspects of Biologics Development Programs including CMC strategy and manufacturing activities at external CDMO's.
  • Develop and direct strategies for upstream and downstream process development, analytics, and formulation development. Partner a cross-functional project team to ensure that project development timelines are in place and aligned with the project's overall objectives.
  • Author and review technical sections for company's global regulatory submissions (INDs, IMPDs, BLAs, MAAs, Meeting Requests, Briefing Documents, responses to Health Authority questions, etc.) related to assigned programs.
  • Proactively collaborate with QA and other members of the project team to efficiently evaluate, select, and manage contract service providers (CDMOs and CROs). This will include technology transfer, process scale-up, design of validation strategies, and providing technical expertise with regards to routine and nonroutine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc.).
  • Oversee the development and maintenance of CMC budget for assigned program activities, including the preparation of cost estimates for new work. Track invoices and proactively verify versus work performed. Partner with Finance and Project Management to periodically review and report on the status of project spend versus the approved budget. Recommend appropriate budgetary adjustments in conjunction with changing project scope and timelines.
  • Develop and/or provide critical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc). Support the creation, maintenance, improvement, and routine use of Quality Systems. Contribute to the generation and protection of company intellectual property.
  • Maintain up-to-date knowledge of pharmaceutical development and manufacturing of biologics
  • Contribute technical CMC expertise in support of the due diligence process to create initial strategies for new compounds, flagging manufacturing risks and considerations as needed

 Required Qualifications 

  • PhD. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field and 5yr+ experience in the pharmaceutical industry.
  • Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics.
  • Must have demonstrated leadership experience in managing diverse project activities with contract CDMO facilities at different global locations.
  • Knowledge of cGMP regulations, ICH guidelines, and the CMC content of global regulatory submissions
  • Track record of successful IND, CTA, NDA, and/or BLA submissions
  • Very strong technical knowledge of pharmaceutical development and manufacturing of biologics, including cell line development, upstream/downstream process development, pre-formulation/formulation development, and analytical development. Knowledge of cell/gene therapy is a plus
  • Experience with process scale-up and technology transfer
  • Intellectual agility - able to pivot based on shifting priorities and balance multiple projects seamlessly
  • Natural collaborator who enjoys working on a cross-functional team
  • Demonstrated communication, problem-solving, and negotiation/decision-making skills