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Immix Biopharma (Nasdaq: IMMX) · 3 weeks ago

CMC Documentation Specialist

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

Immix Biopharma is a global leader in relapsed/refractory AL Amyloidosis, and they are seeking a CMC Documentation Specialist to manage the lifecycle of CMC technical documentation supporting clinical development and regulatory submissions. This role ensures accuracy and compliance of documents while coordinating with various teams to meet regulatory expectations.

Biotechnology

Responsibilities

Manage the end-to-end lifecycle of CMC documents, including drafting support, formatting, version control, review coordination, approval routing, and archival

Manage change control tasks and deliverables

Maintain document trackers for CMC deliverables supporting INDs, BLAs, amendments, annual reports, and regulatory responses

Ensure document consistency across Module 3 sections (3.2.S, 3.2.P), protocols, reports, specifications, and validation documentation

Enforce document naming conventions, templates, and formatting standards in alignment with company SOPs and regulatory expectations

Data verification in all primary and secondary sources

Support preparation of CMC content for regulatory submissions by coordinating inputs from Analytical Development, Process Development, Manufacturing, Quality, and external vendors

Assist in compiling CMC sections for INDs, BLAs, IMPDs, and supplements, including cross-referencing and technical consistency checks

Support responses to regulatory agency questions by tracking commitments, coordinating revisions, and managing final submission-ready documents

Act as a documentation liaison between CMC technical teams, Quality Assurance, Regulatory Affairs, and external partners (CDMOs, CROs, testing labs)

Schedule and manage document reviews, ensuring timely resolution of comments and adherence to project timelines

Track document dependencies and flag risks related to missing inputs, late reviews, or version conflicts

Ensure documentation complies with applicable regulations and guidance (e.g., FDA, ICH, EMA)

Support audit and inspection readiness by maintaining organized, retrievable, and complete CMC documentation records

Assist with document remediation, gap assessments, and updates following audits, inspections, or internal reviews

Maintain and administer document management systems (e.g., eDMS, SharePoint, Veeva, MasterControl)

Support development and improvement of CMC documentation SOPs, templates, and workflows

Identify opportunities to streamline documentation processes, improve clarity, and reduce rework

Qualification

CMC documentation managementRegulatory submission supportDocument management systemsBiologics familiarityGMP-regulated environmentsContinuous process improvementOrganizational skillsClear communication skillsCross-functional collaboration

Required

Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, or a related discipline

3–7 years of experience in CMC documentation, regulatory operations, quality documentation, or technical writing within the biotech or pharmaceutical industry

Hands-on experience supporting CMC documentation for clinical or commercial BLA submissions

Working knowledge of CMC documentation types, including protocols, reports, specifications, validation documents, stability documentation, and regulatory submission content

Familiarity with ICH guidelines and FDA/EMA expectations related to CMC documentation

Proficiency with document management systems and Microsoft Office tools

Exceptional attention to detail and document accuracy

Strong organizational and project-tracking skills

Ability to manage multiple documents and timelines in parallel

Clear written and verbal communication skills, with the ability to work across technical and non-technical teams

Comfortable operating in fast-paced, evolving environments