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This is a fully remote role.
The preference is for candidates local to Cambridge, MA.
The Role:
Reporting to the Senior Director CMC Project Management, this individual will serve as an integral member of the Technical Operations team as a CMC Project Manager. The individual will partner with leads from Pharmaceutical Development, Clinical Supply Chain, Quality Assurance, Regulatory Affairs, Program Management, and Finance to formulate and drive execution of CMC development strategies for one or more products, ensuring alignment with overall program strategies, timelines, risk profile, and budget. Has a passion to develop new medicines for patients with cancer.
The individual will work with the CMC team to coordinate cross functional activities including, but not limited to process development, analytical development, technical transfers, formulation development, clinical manufacturing, regulatory documentation, commercial planning, and vendor management.
The project manager will support technical teams and manage associated projects both in-house and at Contract Development and Manufacturing Organizations (CDMOs). The successful candidate will have a strong understanding of the functional operations of Chemistry, Manufacturing, and Controls supporting development of small molecule/oral solid dosage forms with a history of success in clinical stage CMC project management in the biotechnology industry.
Responsibilities:
Competencies:
Qualifications:
Full Time
$156k-198k (estimate)
01/16/2024
05/09/2024
nuvalent.com
Cambridge, MA
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