Job Details
Posted 18 June, 2026
Job Id: 628388
Analytical SME & CMC Technical Writer
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).
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 inquiries
Skills:
Required
* Demonstrated working experience in regulatory submissions
* Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.)
Preferred
* Experience working with external manufacturing or testing partners
Key Skills
* High attention to detail and scientific rigor
* Effective communication and stakeholder collaboration
* Ability to manage multiple priorities in a fast-paced environment
Education:
- Advanced degree (e.g., PhD) is preferred, or Master’s and Bachelor’s degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
Pay Rate Range: $45-57/hr depending on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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