Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer and lifecycle management
Contribute to development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teams
Contribute to development of DS/DP stability programs and assignment of DS retest period, DP shelf life and material holding times as needed, with internal and external teams to support FIH and following clinical trials
Independently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timeline fashion.
Prepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teams
Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverables
Support departmental submission activities by managing documentation workflow workflow in Veeva RIM system
Demonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documents.

Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations.
Demonstrated working experience in regulatory submissions
Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.)
Preferred Experience in global regulatory submissions (IND, CTA, NDA, MAA)
Experience working with external manufacturing or testing partners

Analytical SME, CMC Technical Writer

Key skills