Role Summary
The successful candidate will be a part of the Process Science group, responsible for process development, in-house non-GMP manufacturing, report and protocol authoring and reviewing, process transfer to CMOs, and stage 1 manufacturing process validation for siRNA oligonucleotides. This role is onsite and lab-based, with the primary location in Cambridge, MA.
Responsibilities
- Design and conduct laboratory experiments, analyze results, and draw meaningful conclusions.
- Support downstream processing method optimization.
- Execution of oligonucleotide downstream processes to provide the research and in-house non-GMP material in a tight timeline.
- Execution of in-process analytical tests.
- Participate in creating and reviewing SOPs and batch records in support of the in-house non-GMP manufacture.
- Oligonucleotide manufacturing, process development, optimization and scale up.
- Operation and optimization of downstream processing.
- Manufacturing of oligonucleotide APIs in a cGLP environment.
- Operation of analytical instruments and application of analytical techniques.
Qualifications
- BS in Chemical Engineering or Chemistry with a minimum of 2 years lab experience, preferably in an industrial setting.
- Basic understanding of analytical techniques (pH, osmolality, conductivity measurement, HPLC, LC-MS etc.). Related hands-on experience is preferred.
- Knowledge of oligonucleotide manufacture process including phosphoramidite chemistry, chromatography, ultrafiltration etc. is a plus.
- Experience in record-keeping and excellent laboratory documentation practice, are required. Strong commitment to high laboratory and scientific standard.