Analytical Development Scientist job in Cambridge, USA

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Job type: Permanent

Discipline: Biochemistry, Biological Sciences, Toxicology

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

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