Sigma Systems, Inc. · 1 month ago
Analytical SME & CMC Technical Writer (Remote)
United States
Full-time
Remote
Senior Level
6+ years expSigma Systems is seeking an experienced Analytical Subject Matter Expert (SME) & CMC Technical Writer to support external Drug Substance and Drug Product development programs within a global pharmaceutical environment. The successful candidate will collaborate with cross-functional teams and external partners to support analytical strategies, technical documentation, and global regulatory filings.
EducationFinanceSoftwareFinancial Services
Responsibilities
Provide scientific leadership for Drug Substance (DS) and Drug Product (DP) analytical development and quality control activities
Support analytical method development, validation, transfer, and lifecycle management
Develop and review phase-appropriate analytical control strategies and specifications
Contribute to stability programs, retest period assignments, shelf-life determinations, and material holding time evaluations
Review and provide input on quality agreements, statements of work (SOWs), study protocols, technical reports, and analytical data packages
Analyze batch and stability data to support regulatory and development milestones
Partner with CDMOs, CROs, and internal stakeholders to address analytical and quality-related challenges
Prepare technical presentations, reports, and project updates for cross-functional teams
Author, review, and edit CMC documentation for global regulatory submissions
Support preparation and maintenance of CTD Module 3 documentation for Drug Substance and Drug Product
Manage submission documentation workflows within Veeva RIM
Contribute to IND, CTA, NDA, and MAA submissions and responses to regulatory authorities
Ensure documentation complies with FDA, EMA, ICH, USP, EP, GMP, and other global regulatory requirements
Maintain consistency, scientific accuracy, and compliance across regulatory submission documents
Qualification
Required
Bachelor's, Master's, or PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline
Minimum 6+ years of pharmaceutical or biotechnology industry experience in CMC, analytical development, or quality control
Experience supporting New Chemical Entity (NCE) and NCE-like development programs
Demonstrated experience with analytical method development, validation, transfer, and lifecycle management
Experience authoring, reviewing, and editing CTD Module 3 documentation
Working knowledge of Veeva RIM document management systems
Experience supporting regulatory submissions and health authority interactions
Strong technical writing, communication, and organizational skills
Ability to manage multiple projects and deadlines in a fast-paced environment
Preferred
PhD preferred
Experience supporting IND, CTA, NDA, and MAA submissions
Experience with oligonucleotide, biologic, or small molecule development programs
Experience working with CDMOs, CROs, and external manufacturing/testing partners
Strong knowledge of GMP regulations and global regulatory requirements
Familiarity with FDA, EMA, ICH, USP, and EP guidelines
Company
Sigma Systems, Inc.
Welcome to Sigma Systems! We are poised to meet the evolving needs of post-secondary educational institutions across the United States in the wake of the Congressional FAFSA Simplification Act.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase