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.)
Experience in global regulatory submissions (IND, CTA, NDA, MAA)
Requirements:
Provide scientific leadership in phase appropriate external DS/DP analytical development/QC.
Contribute to development of DS/DP phase appropriate specifications and analytical control strategies.
Prepare and communicate clearly technical plans, updates, and deliverables.
Support departmental submission activities by managing documentation workflow in Veeva RIM system.
Job description
Duties:
We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD) at the client.
This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and technical writing capabilities to support documentation and global regulatory submissions (e.g., IND, CTA, NDA/MAA).
The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations.
Key Responsibilities
Analytical Expertise
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
CMC Technical Writing
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.
Contribute to preparation of regulatory submissions/briefings and responses to health authority inquirie
Skills:
Required
• 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
Key Skills
• Strong organization and technical writing skills
• High attention to detail and scientific rigor
• Effective communication and stakeholder collaboration
• Ability to manage multiple priorities in a fast-paced environment
