Senior Analytical QC Chemist-GMP

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POST DATE 9/17/2016
END DATE 12/3/2016

WAVE Life Sciences Cambridge, MA

Company
WAVE Life Sciences
Job Classification
Full Time
Company Ref #
361031
AJE Ref #
576206224
Location
Cambridge, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Wave Life Sciences is seeking an Sr. Analytical QC Chemist to be responsible for the development, validation, qualification, and implementation of analytical test methods in support of process development, GMP production, and stability testing with particular emphasis on UPLC and LC-MS methods. The successful candidate must have extensive, hands-on experience in the development and validation of stability-indicating and quantitative assays in cGMP environment. Proven ability to develop highly specific analytical methods for a wide variety of large molecule/biotechnology compounds. Exceptional cGMP documentation skills is a must for this position. Ability to adapt to a fast pace dynamic environment where priorities can change rapidly.
Ideal candidate will have experience in oligonucleotide method development and validation.

RESPONSIBILITIES
* Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.).
Prepares and executes validation and qualification protocols and reports
Identifies, evaluates, and procures analytical equipment and reagents
Performs method validation and qualification
Analyzes research and productions samples
Prepares scientific reports and documents, presents analytical findings and uses scientific literature to solve advanced technical problems.
Prepares and reviews SOPs, test methods, scientific reports and other GMP/regulatory documentation
Reviews data generated by other analysts
Independently applies scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems.
Mentors and trains junior chemist and scientist and acts as an analytical chemistry resource for other staff
Participate in project management activities including: creating and meeting objectives for timelines, budgets, and project goals.
Troubleshoots analyses and performs investigations
Performs routine testing when required