Scientist I

Scientist I
  • Competitive
  • Temporary
  • Cambridge MA, US Cambridge MIDDLESEX US 02142
Job Ref: JO000123531
Sector: Clinical
Sub-sector: Quality
Date Added: 04 October 2021

Analytical Development Scientist - Contract

The successful candidate will serve a key role in Analytical Development, being responsible for qualification of reference materials and providing analytical support to Process Development and Toxicology groups using a variety of analytical techniques. The researcher will be responsible for executing analytical testing of siRNA drug substance, drug product, and related materials to enable non-clinical studies, and will also support the qualification and characterization of reference materials used within Analytical Development for early-stage programs, ensuring continuous supply and life cycle management of reference materials throughout the organization.

Summary of Key Responsibilities:

• Performs complex testing and sophisticated data analysis of in-process and final formulation siRNA drug substance and drug product and related materials utilizing the following analytical techniques: LC/UV and LC/MS assays, osmolality, LAL endotoxin assay, UV/VIS, melting temperature and pH. Oversees the resolution of testing problems with minimal supervision

• Execute analytical qualification activities for early phase reference materials including authoring of protocols and reports

• Author and/or review Certificates of Testing for critical siRNA as needed

• Provide technical support for Toxicology by performing dosing concentration analyses and authoring reports

• Coordinate aliquoting and shipping of materials to external laboratories as needed

• Evaluate new technologies and method improvements as needed

• Train staff members on relevant analytical techniques as needed

• Must exhibit excellent leadership, interpersonal and teamwork skills

• Manages multiple tasks and competing priorities effectively, with a focused attention to detail

• Shows flexibility and helps define appropriate testing schedules for multiple programs


• BS or MS in Chemistry, Biochemistry or related disciplines

• 2+ years of pharmaceutical industry experience

• Familiarity with cGMP, ICH and regulatory guidelines. Prior experience in GMP and Regulatory settings a plus

• Direct experience in liquid chromatography separation systems (hardware and software) is preferred

• Experience with oligonucleotide assays is preferred

• Support and facilitate Data Review and Generation of Certificates of Testing. Extend re-test dates for reference mater

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.


31/10/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Tyler Rostad

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