The Senior Associate Scientist, Specifications will be responsible for specification support of siRNA drug substances and drug products. This is an onsite position.



Summary of Key Responsibilities:

• Initiate and manage specification change controls in a GMP setting.


• Expected contributions to general operations including review of data and authorship/review of technical documentation. Provide technical support as needed.


• Author and review SOPs and protocols in accordance with company and regulatory guidelines.


• Contribute to data review, analytical and stability sections of regulatory submissions. Assist with responses to agency requests on these sections.


• Contribute to specification assessment of existing and new products.


• Provie support in maintaining platform program specification documents.

Knowledge/Experience/Skill:

"BS or MS...