Principal Associate Scientist, Analytical Sciences
About The Position
This role involves performing analytical testing of siRNA drug substances, drug products, and critical raw materials. The Principal Associate Scientist will also be responsible for authoring and reviewing stability protocols, reports, and SOPs. A key aspect of the position is contributing to the design and execution of special use stability studies using Design of Experiments (DoE) principles, including freeze-thaw, thermal cycling, compatibility with injection devices, and in-use studies. The role supports outsourced GMP/GxP stability programs and requires providing statistical interpretation of stability data in relation to release and lifetime specifications. Additionally, the scientist will contribute data to regulatory submissions, assist with agency responses, and investigate stability Out of Trend (OOT) results. Ownership of Change Controls and CAPA, and providing stability expertise for temperature excursion assessments are also core responsibilities.
Requirements
- Master’s degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and four (4) years of experience in the job offered or related occupation.
- OR Bachelor’s degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and seven (7) years of experience in the job offered or related occupation.
- Demonstrated experience with Analytical Instruments and Techniques (HPLC, UPLC, US spectroscopy or pH).
- Demonstrated experience with analytical data review, interpretations, and trending.
- Demonstrated experience with statistical analysis of data and interpretations.
- Demonstrated experience with Investigations, Deviations and Change Controls.
- Demonstrated experience with stability studies designed and conducted in accordance with ICH stability guidelines.
- Demonstrated experience with technical writing.
- Demonstrated experience in an analytical laboratory environment (cGMP).
Responsibilities
- Perform analytical testing of siRNA drug substances, drug products, and critical raw materials.
- Author and review stability protocols, reports, and SOPs.
- Contribute to the design and execute special use stability using sound DoE principles (e.g., freeze-thaw, thermal cycling, compatibility with intended injection device, and in-use studies).
- Support outsourced GMP/GxP stability programs for drug substance and drug product.
- Provide sound statistical interpretation of stability data, and their relation to release and lifetime specifications.
- Contribute data to characterization, analytical, and stability sections of regulatory submissions.
- Assist with responses to agency requests on these sections.
- Contribute to investigations of stability Out of Trend (OOT) results.
- Contribute as owner of Change Controls and CAPA.
- Provide stability expertise to the assessment of temperature excursions.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
