More jobs:
Director, Biologics CMC Technical Writing
Remote / Online - Candidates ideally in
Fort Worth, Tarrant County, Texas, 76102, USA
Listed on 2026-10-09
Fort Worth, Tarrant County, Texas, 76102, USA
Listing for:
Scorpion Therapeutics
Remote/Work from Home
position Listed on 2026-10-09
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Director of Biologics CMC Technical Writing, leading preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions like BLA. Objectives include developing strategic content for biologics, especially drug substance processes, ensuring regulatory readiness, and managing cross-functional collaborations.
Responsibilities- authoring and coordinating Module 3 sections
- translating technical data into clear narratives
- developing document strategies
- supporting responses during review
- overseeing document reviews and approval workflows
- collaborating with internal teams and external partners
- a Bachelor’s in pharmaceutical sciences, chemical engineering, or biotech with 10+ years' industry experience
- expert in biologics development, manufacturing, analytical control, and related areas
- extensive experience authoring regulatory CMC content for biologics submissions, particularly modules 2 and 3
- strong scientific judgment, communication, and leadership skills
- advanced degrees (M.S./Ph.D.)
- experience with microbial fermentation
- experience with lyophilized drug products
- experience with combination products
- experience with device-related activities
- experience with FDA interactions, regulatory responses, and delivering presentations at high levels.
- biologics
- recombinant proteins
- microbial fermentation
- late-stage biologics
- regulatory submission strategy
- cross-functional leadership
Work setup includes remote work with approximately 10% domestic and international travel.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×