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Job Details

Analytical Development Staff Scientist

Location
Lexington, MA, United States

Posted on
Sep 10,2019

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Description:
Scope:
**MEMBERS ONLY**SIGN UP NOW***. is seeking an experienced scientist to join a growing QC/Analytical Development function within CMC operations at a recently commissioned, state-of-the-art GMP oligonucleotide therapeutics manufacturing facility. Wave has pioneered a proprietary chemistry platform that enables the precise design, optimization and production of stereopure oligonucleotides. This position offers the opportunity to provide leadership in the overall long-term analytical development program for one or more of Wave's novel platform products in a fast-paced environment. The Analytical Development Scientist will be responsible for the development, implementation and qualification/validation of analytical methods for transfer into routine and non-routine use. This role will also have responsibility for detailed chemical and structural characterization of oligonucleotides, raw materials and impurities. Our labs are well equipped with technology for high resolution Mass Spectrometry and MS/MS, NMR spectroscopy and UPLC-based separations. The scientist in this role will provide critical GMP and non-GMP reports and other documents to enable project milestones,and will interact across internal departments and with CROs/CMOs. In addition, there will be regular opportunities to provide mentorship and guidance to other staff within CMC operations, often through method transfer, qualification and related activities.

Responsibilities:
Development and deployment of MS, UPLC, NMR and other methodologies for characterization, profiling and/or quantitation of oligonucleotides, impurities and raw materials.
Leads and supports method qualification and validation.
Leads or supports development, troubleshooting, improvement and life-cycle management of analytical methods, investigations, process characterization and other cross-functional activities.
Write, review and approve GMP documentation (technical reports, protocols, validations, test methods, specifications, etc.).
Identifies, evaluates, and procures analytical equipment and reagents to enhance capabilities of the department.
Maintains awareness of state of the art technologies in scientific literature and in pharma/biotech industry.
Presents/communicates analytical findings and draws from scientific literature and in-house expertise to solve advanced technical problems.
Mentors and trains colleagues in QC/Analytical function.
Reviews data packages, protocols, reports generated by other technical staff.
Develops strong rapport with colleagues in the QC/Analytical department, as well as with colleagues in Quality Assurance, Manufacturing, Process Development, Bioanalytical, Chemistry.
Independently applies scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems.
Works effectively and efficiently with external labs to provide testing and development support for Wave's programs.
Education / Experience:
PhD in Analytical Chemistry, Biochemistry, Biotechnology or related discipline, with 3-5 years of analytical chemistry experience in pharma/biotech/cGMP, or MS with a minimum of 8 years of analytical chemistry experience.
Hands-on industrial experience with Mass Spectrometry and chromatography required
Experience with NMR and other instrumental techniques is highly preferred
cGMP experience in an analytical development or QC setting is preferred
Proven ability to adapt and learn in a fast paced environment with rapidly changing priorities
Expertise in a broad range of analytical chemistry, biochemistry or biophysical methods, including Mass Spectrometry of complex molecules, UPLC, NMR, Karl-Fischer, UV-Vis, FT-IR, Gas Chromatography.
Experience with oligonucleotide or peptide experience preferred but not required
Training in quality systems, regulatory, synthetic chemistry, Waters-Empower is a plus.
Full computer literacy (Word, Excel, Powerpoint, databases, electronic documentation), knowledge of basic scientific principles and practices, and ability to effectively communicate and collaborate both verbally and in written communications.
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Job Information
Location:
Lexington, Massachusetts, United States
Job ID:
50580918
Posted:
September 10, 2019
Position Title:
Analytical Development Staff Scientist
Company Name:
**MEMBERS ONLY**SIGN UP NOW***.
Job Function:
Other / Not Listed
Entry Level:
No
About **MEMBERS ONLY**SIGN UP NOW***.
We are leading a new era of precision medicine in which rationally designed oligonucleotides are the key to delivering safer, more effective medicines.
These include potentially transformational therapies for conditions where there are currently few or no treatment options. We aspire to help create a world in which every patient with a genetic disease will have access to life-changing treatments in their lifetime.
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