Analytical SME and CMC Technical Writer

Aptask Global Workforce (AGW) is seeking an Analytical SME and CMC Technical Writer for a contract position with a Major Pharmaceutical Company located in CT. This is a 12 month contract opportunity.

This role combines deep expertise in drug substance/drug product analytical development and quality control with technical writing capabilities to support documentation and global regulatory submissions. The successful candidate will collaborate with internal cross-functional teams and external partners to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations.

Responsibilities:

• Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like entities, including method development, validation, transfer and lifecycle management
• Contribute to the development of DS/DP phase appropriate specifications and analytical control strategies
• Contribute to the development of DS/DP stability programs and assignment of DS retest period and DP shelf life
• Independently propose or review quality agreements, SOWs, study protocols/reports, and batch/stability data
• Prepare and communicate technical plans, updates, and deliverables in reports and presentations
• Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events
• Support departmental submission activities by managing documentation workflow in Veeva RIM system
• Author, review, and edit CTD Module 3 (Drug Substance and Drug Product) documents
• Contribute to the preparation of regulatory submissions/briefings and responses to health authority inquiries

Requirements:

• Advanced degree (PhD, Master's, or Bachelor's) in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline
• 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.)
• Strong organization and technical writing skills
• High attention to detail and scientific rigor
• Effective communication and stakeholder collaboration skills
• Ability to manage multiple priorities in a fast-paced environment

Desired skills:

• Experience in global regulatory submissions (IND, CTA, NDA, MAA)
• Experience working with external manufacturing or testing partners

Pay rate: up to $59.28 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

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