Randstad Clinical Operations in Lexington, Massachusetts

Clinical Operations

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job details:

  • location:Lexington, MA

  • salary:$35.49 - $41.75 per hour

  • date posted:Monday, October 9, 2017

  • job type:Contract

  • reference:22854

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Development Specialist III

Job Responsibilities

  • Complete assigned activities relating to design/interpretation of scientific experiments in pre-formulation / pharmaceutical property assessment

  • Responsible for the completion of pre-formulation and formulation experiments leading to the improvement of long-term stability of proprietary drug products

  • Develop freeze-dried/liquid formulation of biologics

  • Responsible for the analysis of stability samples

  • Interpret data from experiments performed to assess stability of drug substance and product

  • Works directly with other scientists, analytical staff, and quality groups internally to assure completion of delegated tasks that provided results are on-time, documented, technically sound and robust.

  • Author/review development documents

Education & Qualifications

  • B.S and/or M.S in Pharmaceutical Science, Pharmacy, Biochemistry, Chemistry, or Chemical Engineering

  • 3+ years industry experience in pre-formulation assessments, drug delivery or biologics formulation development

  • Excellent interpersonal skills

  • Strong problem solving abilities with a strong work ethic and dedication to completion of assignments

  • Demonstrated written and oral communication skills

  • Familiar with the development of freeze-dried formulations of biologics

  • Familiar with HPLC techniques such as reverse phase, SEC, IEC

  • Familiar with cGMPs and Quality Assurance Guidelines

  • Must be well-organized and self-motivated, and possess an independent work style.

  • Excellent oral and written communication skills including the ability to deliver good presentations and well written technical documents.

  • Demonstrate sound scientific judgment in decision-making while keeping open communications to ensure that all work and deliverables are timely and of high quality

  • Works closely with Project leads

  • Interacts with external partners including testing laboratories, CROs and CMOs

  • Some domestic travel may be necessary