Remote Associate Director, Analytical Development & Strategy

Cogent Biosciences, Inc.; United States; Remote; USD 185.000 - 215.000; Vollzeit

Benefits dieser Stelle

Bonus program

Stock awards

Fully funded healthcare (medical, 2+ 2

Zusammenfassung

Cogent Biosciences, Inc. is seeking an Associate Director, Analytical Development, to lead analytical activities across development and commercial portfolios.

The role partners with Regulatory CMC, Quality, and external CDMOs to ensure data integrity and regulatory-ready documentation. The position focuses on method development, validation/transfer, lifecycle management, and support for regulatory submissions, with emphasis on high-quality documentation and cross-functional collaboration.

Qualifikationen

• PhD/MD/PharmD level with extensive industry experience in analytical development.
• Experience authoring regulatory documentation and technical reports.
• Strong understanding of small molecule analytical development and validation.

Aufgaben

• Lead preparation, review, and approval of analytical reports, data summaries, protocols, and methods.
• Review data packages for release testing, stability studies, and drug product manufacturing.
• Coordinate with Regulatory CMC, Quality, and CDMOs for timely analytical documentation.

Kenntnisse

Analytical development

CMC technical writing

Regulatory knowledge

Data interpretation

Project management

Ausbildung

PhD in Chemistry/Pharmaceutical Sciences or related

Master’s degree with 10+ years experience

Bachelor’s degree with 12+ years experience

Tools

HPLC/UPLC

GC

Dissolution

Spectroscopy

Mass spectrometry

Jobbeschreibung

Cogent Biosciences, Inc. is seeking an Associate Director, Analytical Development, to lead analytical activities across development and commercial portfolios.

The role partners with Regulatory CMC, Quality, and external CDMOs to ensure data integrity and regulatory-ready documentation. The position focuses on method development, validation/transfer, lifecycle management, and support for regulatory submissions, with emphasis on high-quality documentation and cross-functional collaboration.