CMC Technical Writer

Rangam International • Santa Monica, CA

224d • $78

About The Position

The CMC Technical Writer position is a contractor role within the Process Development organization. The individual will support internal Process Development teams and will be involved in time-critical CMC Regulatory submissions. In the long term, the individual will be embedded in technical teams within the Process Development department, supporting CMC aspects of growing pipeline projects.

Requirements

• Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent.
• 7+ years of relevant experience with a Bachelor's degree, 5+ years with a Master's degree, or 3+ years with a PhD.
• Experience with CMC/Module 3 regulatory submissions.
• Proficient in technical writing and high-quality writing.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and analytical and process development.
• Thorough knowledge of biologics analytical and process development.
• Knowledge of product lifecycle including product and process development, clinical trials, validation, regulatory submissions, and commercial GMP manufacturing.
• Working knowledge of regulatory requirements for biologics, pharmaceuticals, and medical devices.
• Ability to function as part of a team and contribute to team-based decisions.
• Excellent communication skills.
• Critical thinking and problem-solving skills.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills and fluency with Microsoft Office applications.
• Excellent interpersonal, verbal, and written communication skills.

Nice To Haves

• Cell therapy process development experience.

Responsibilities

• Author and finalize appropriate Module 3 documents and responses to agency questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
• Support time-critical CMC Regulatory submissions.
• Contribute to the development of analytical methods for vector and T cell products.
• Ensure compliance with ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.

What This Job Offers

• Career Level: Mid Level
• Education Level: Master's degree