Lexington Categories:
Senior Scientist/ Principal Scientist, Analytical Chemistry Concert Pharmaceuticals
THIS JOB HAS EXPIRED
Description:The Senior Scientist/ Principal Scientist position will be responsible for leading all analytical chemistry development issues within one or more small-molecule CMC development programs, including method development and validation, analytical investigations, stability programs, and process and product characterization. The qualified individual will collaborate with CMO?s and CRO?s to transfer analytical technologies to manufacturing sites, and be responsible for thorough analytical characterization of manufacturing processes. The position may involve supervision of subordinate scientific staff.
Strong organizational and communication skills are required to collaborate with other staff and to complete required activities in a timely manner. The individual must be able to handle multiple competing priorities in a fast paced environment. Good presentation skills are required. The individual must pay attention to details.
Responsibilities:
Lead CMC Analytical activities for one or more development programs
Develop robust and phase-appropriate analytical methods to characterize and improve Drug Substance and Drug Product manufacturing processes
Validate methods appropriate to phase of development
Oversee stability program to support clinical development and regulatory filings
Transfer technology to selected vendors
Work with vendors to ensure sound Analytical data and results are reported
Summarize data and scientific findings in presentations and reports
Contribute to regulatory filings
Contribute to the development of product specifications
Manage subordinate scientific staff as appropriate
Qualifications:
PhD in Analytical Chemistry with 4+ years of experience or equivalent
Demonstrated expertise with HPLC, GC
Experience with Drug Substance and Drug Product Method Development and Validation
Experience with Analytical technology transfer to manufacturing sites
Demonstrated ability to troubleshoot Analytical results
Ability to identify and address CMC issues
cGMPs, ICH Guidelines and other regulatory requirements
Some experience in solid state characterization techniques (DSC, TGA, XRPD) preferred
Some experience with MS, NMR, Spectroscopy, and Wet Chemistry preferred
| Location: | 99 Hayden Avenue Suite 100 Lexington, MA 02421 United States |
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THIS JOB HAS EXPIRED
Concert Pharmaceuticals
Investors: Flagship Ventures, Greylock Partners, Mediphase Venture Partners, New Leaf Venture Partners, Three Arch Partners, TVM CapitalAll Jobs: at Concert Pharmaceuticals
| Web Site: | www.concertpharma.com |
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| Headquarters: | 99 Hayden Avenue Suite 100 Lexington, MA 02421 United States |
| Industry: | Biotechnology |
