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Job Details

Associate Director CMC 226035

Company name
Black Diamond Networks

Location
Andover, MA, United States

Employment Type
Full-Time

Industry
Manager

Posted on
Jun 26, 2020

Valid Through
Oct 09, 2020

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Associate Director CMC (226035)

Life Sciences & Technology | Clinical Research & Clinical Affairs

Location

: Company is based in New Jersey but the assignment will be remote

Duration

: 3-6 Months

Job Description:

A Black Diamond client is looking for an experienced CMC consultant with a strong background in formulation and drug product and in-depth knowledge of pharmaceutical development.

In the immediate term, the consultant will provide support for antibody drug conjugates (ADCs) program including tech transfer activities to CMO/CDMOs. Beyond ADCs, the company has other platforms/technologies including monoclonal antibodies, peptides, other biologics and small molecule drugs that will require technical input/expertise from the consultant. The consultant will be part of CMC sub team which includes members from QA, regulatory, formulation, process chemistry, analytical development, etc. and will be providing the DP/formulation expertise to the team. Will provide review & CMC input for regulatory documents, manage/liaise with CDMOs, work on scale-up and tech transfer activities.

The right candidate would have significant experience (technical CMC/pharma development), clinical and commercial experience, strong verbal and written communication skills and experience working with international teams (the clients team is in US, Germany and Japan). Previous experience working for a Japanese company would be an added bonus, but certainly not required.

JOB ID #226035

#LI-NG1

ASAP

Remote

Company info

Black Diamond Networks
Phone : 800-681-4734
Website : http://www.blackdiamondnet.com

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