Overview
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Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision Right Talent. Right Time. Right Place. Right Price.
Title: CMC Technical Writer
Location: Santa Monica, CA 90404 (Hybrid)
Duration: 06 months (Extendable)
Overview
Client is seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. This position is part of the Process Development organization, supporting internal Process Development teams. In the near term, this role will support time-critical CMC regulatory submissions; longer term, the individual will be embedded in technical teams within Process Development, supporting CMC aspects of growing pipeline projects.
Responsibilities (include but are not limited to)
- Author and finalize appropriate Module 3 documents and responses to agency questions in collaboration with Regulatory CMC and technical subject matter experts
- Apply expertise in analytical method development of vector and T cell
- Conduct extended characterization of vector and T cell products
- Maintain awareness of ICH guidelines and global compendial requirements governing analytical development and characterization/comparability of advanced therapy medicinal products and vector intermediates
Requirements
- Bachelor's, Master's, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry, or equivalent
- 7+ years (Bachelor's), 5+ years (Master's), or 3+ years (PhD) relevant experience
- Experience with CMC/Module 3 regulatory submissions
- Technical writing proficiency with high-quality documentation skills
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and analytical and process development
- Thorough knowledge of biologics analytical and process development; cell therapy process development experience highly desired
- Knowledge of product lifecycle, including product and process development, clinical trials, validation and regulatory submissions, and commercial GMP manufacturing
- Working knowledge of regulatory requirements for biologics, pharmaceuticals, and medical devices
- Team-oriented mindset with excellent communication skills and collaborative decision-making ability
- Critical thinking skills with demonstrated troubleshooting and problem-solving abilities
- Self-motivated and adaptable to temporary responsibilities outside of the initial job description
- Proficiency with Microsoft Office applications
- Excellent interpersonal, verbal, and written communication skills in a collaborative environment
- Ability to work in a fast-paced environment with minimal direction and adjust workload based on changing priorities
Why Work With Us?
We believe in more than just jobs we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.
Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.
Awards & Recognition
* America's Most Honored Businesses (Top 10%)
* Fastest-Growing Staffing Firm by Staffing Industry Analysts
* INC 5000 List for Eight Consecutive Years
* Top 100 by Dallas Business Journal
* Spirit of Alliance Award by Agile1
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