Principal Associate Scientist

Solid Biosciences•Boston, MA

2d•$0 - $110,000•Onsite

About The Position

Responsible for analytical development, qualification and operational support for Preclinical, Phase 1 and Phase 3 of clinical products. Support the development and execution of analytical methods directly related to process development cGMP manufacturing of Solid Biosciences leading candidate. This role involves lab operations such as routine and non-routine analytical testing, coordination with internal/external PD or cGMP Manufacturing, critical reagent qualification, maintaining laboratory equipment and inventory, and compiling/presenting data to support process development and stability. The position also involves supporting the development of new methods by identifying, evaluating, and executing analytical methods to meet ongoing analytical needs. Additionally, it requires participation in the support of manufacturing activities at CMOs and CTOs related to analytics, including coordinating testing, shipments, inventory, data review, and reporting. The role demands maintaining well-documented records of analytical data, laboratory notebooks, assay execution, and stability data. The Principal Associate Scientist will act as a subject matter expert, involved in updates to Operational and Senior Management teams, and may have responsibility for the management and mentorship of junior scientists. Participation in the technology transfer of analytical methods, protocols/procedures, and know-how from internal labs to CMOs/CTOs, or between CMOs/CTOs, is also a key responsibility, along with contributing towards assay qualification at CMOs/CROs. Travel required 10% of the time, domestic only.

Requirements

Master’s of Science in Biotechnology, Microbiology, Biology, Genetics or related field (or foreign equivalent).
Two (2) years of experience in analytical development or quality control within a biotech/pharmaceutical process development or manufacturing environment.
One (1) year of experience with molecular and cell based analytical methods including cell culture, In vitro cell based assays, ddPCR, qPCR, ELISA.
One (1) year of experience working in cGMP supporting analytical development/Quality control environment with an understanding of regulatory requirements and trends related to product quality.
One (1) year of experience with Electronic Lab Notebook (ELN).
One (1) year of experience with compliance and cGMP considerations.

Responsibilities

Analytical development, qualification and operational support for Preclinical, Phase 1 and Phase 3 of clinical products.
Support the development and execution of analytical methods directly related to process development cGMP manufacturing of Solid Biosciences leading candidate.
Perform routine and non-routine analytical testing.
Coordinate with internal/external PD or cGMP Manufacturing.
Critical reagent qualification.
Maintain laboratory equipment and inventory.
Compile and present data to support process development and stability.
Support the development of new methods by identifying, evaluating and executing analytical methods.
Participate in the support of manufacturing activities at CMOs and CTOs related to analytics including coordinating testing, shipments, inventory, data review and reporting.
Maintain well documented records of analytical data, laboratory notebooks, execution of assays and stability data.
Act as subject matter expert and involved in updates to Operational and Senior Management teams.
May have responsibility for management and mentorship of junior scientists.
Participate in tech transfer of analytical methods, protocols/procedures and know-how from internal labs to CMOs/CTOs, or between CMOs/CTOs.
Contribute towards assay qualification at CMOs/CROs.