Analytical Development Scientist

Highly Competitive Salary
  1. Permanent
  2. Biochemistry, Biological Sciences, Toxicology
  3. United States
Cambridge, USA
Posting date: 26 Jan 2021

Proclinical is currently recruiting for an Analytical Development Scientist with a pharmaceutical company located in Cambridge, MA.

Job Responsibilities:

  • Performing in-house microbiology assays and support clinical batch data analysis by becoming the resident SME in microbiology related topics of siRNA clinical products.
  • Assist with drafting and data verification of characterization, analytical, and stability sections of regulatory submissions.
  • Assist with and/or author technical documentation (e.g. SOPs, reports) with appropriate level of guidance, when needed.
  • Support characterization and re-qualification of Early-phase Reference Materials and in-process Formulations, using HPLC, UV/VIS, pH, osmometer, endotoxin assays, as needed.
  • Perform routine testing and data analysis of siRNA utilizing the following analytical techniques: bioburden and sterility, osmolality, LAL endotoxin assay, UV/VIS, HPLC and pH.
  • Support and facilitate Data Review and Generation of Certificates of Testing. Extend re-test dates for reference materials, when applicable
  • Provide support for PD formulation, Toxicology and Analytical groups, as needed.
  • Manages multiple tasks and manages competing priorities effectively.
  • Position requires approximately 50% time on hands-on bench work.

Skills and Requirements:

  • Master's or bachelor's degree with 5 years or 10 years biopharmaceutical experience respectively, with demonstrated microbiology, analytical chemistry and document writing expertise.
  • Hands on knowledge and technical skills to perform microbiology analytical methods such bioburden, sterility and endotoxin, with subsequent data analysis.
  • Self-motivated, with excellent communication, writing and data reviewing skills.
  • Experience in technical oversight of outsourced analytical work is a plus.
  • Established background in technical QC and GMP experience and ICH guidelines, USP/EP/JP.
  • Previous experience with oligonucleotide assays is preferred.

If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.