Associate Director / Director Concert Pharmaceuticals
THIS JOB HAS EXPIRED
Description: The Associate Director / Director position is responsible for the hands-on scientific management of one or more development and/or pre-development projects charged with delivering API to support the organization. The Associate Director / Director will integrate their skills and knowledge of synthetic chemistry and cGMP manufacture to support late-stage research chemistry and enable rapid entry into development. In addition, s/he will identify outsourcing partners and ensure delivery of manufacturing goals.
Responsibilities:
Provide scientific and managerial leadership for Process Chemistry within the CMC team.
Undertake hands-on laboratory experiments as required
Ensure successful development and manufacture of API and supporting CMC activities for early and mid-stage small-molecule drug candidates
Manage process chemistry outsourcing activities
Propose and actively manage departmental budgets for API development and manufacture
Produce high-quality documentation in support of regulatory filings
Manage junior members of the CMC team as required
Qualifications:
PhD in organic chemistry with pharmaceutical industry experience
7+ years experience of process chemistry and cGMP manufacture
Experience in project leadership
Accomplished management experience
Demonstrated leadership and technical proficiency in synthetic organic chemistry, especially early-phase API delivery activities
Extensive knowledge of ICH/FDA guidances and CMC-related regulatory requirements
| Location: |
99 Hayden Avenue
Suite 100
Lexington, MA 02421
United States
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THIS JOB HAS EXPIRED