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Director of Pivotal Product Development

Status: Active
CompanyRVAC Medicines
LocationBoston, MA
Expiration2023-06-14
How to Apply

Please send you resume to CareerDevelopment@rvacmed.com

Responsibilities:

1. Develop scale-up/scale-out drug substance (DS) process for the late-stage/commercial.  DS will consist of pDNA and linearized & modified m-RNA.

2. Lead technological and process innovations in IVT process to enhance the process yield and quality.

3. Working closely with MSAT, provide tech transfer for DS to GMP clinical & commercial sites.

4. Responsible for authoring CMC related sections for global regulatory filings such as IND, IMPD, BLA. 

5. Lead CMC teams on one or more portfolio projects and represent CMC on Product Development Committees to strategic decision making.

6. Evaluate new scale-up technologies to reduce Cost of Goods (COGs).

7. Provide leadership and supervision to scientific staff and group leaders

8. Develop, coach and mentor team members and members on CMC teams 

9. Represent drug substance function in agency deliberations such as pre-IND and pre-BLA meeting, working in close collaboration with Reg-CMC Director

Qualification:

1. Deep expertise in DS process development, specifically using m-RNA platform

2. 6-8 years of relevant industry experience

3. CMC development for early-stage projects up to Ph1/Ph2

4. MS with 12 yrs of relevant industry experience

5. PhD with 6-8 yrs of relevant industry experience

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