Director, Biologics CMC Technical Writing

Scorpion Therapeutics; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of Biologics CMC Technical Writing to lead the creation of Chemistry, Manufacturing, and Controls documentation for regulatory submissions such as BLA. You will translate complex biologics data into clear narratives, develop document strategies, and guide cross-functional teams through reviews and approvals while remote work with roughly 10% travel.

This role demands deep expertise in biologics development, manufacturing, analytical control, and extensive

Qualifications

• Bachelor’s degree 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.

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.

Skills

Scientific judgment

Communication

Leadership

Cross-functional collaboration

Education

Bachelor's in pharmaceutical sciences, chemical engineering, or biotech

Job description

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

Requirements

• 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

Preferred Qualifications

• 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.

High-value specifics

• biologics
• recombinant proteins
• microbial fermentation
• late-stage biologics
• regulatory submission strategy
• cross-functional leadership

Work setup

Work setup includes remote work with approximately 10% domestic and international travel.