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