Scientist I

Scientist I
  • Competitive
    HOUR
  • 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

Requirements

• 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.

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

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