R&D Partners is seeking to hire a CMC Technical Writer/Technical Role in Santa Monica, CA .
Your main responsibilities as a CMC Technical Writer/Technical Role:
Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts
Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.
What we are looking for in a CMC Technical Writer/Technical Role:
Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience
Experience CMC/Module 3 regulatory submissions
Experience in technical writing and proficient in 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 is essential. Cell therapy process development experience is highly desired
Why Choose R&D Partners ?
As an employee, you have access to a comprehensive benefits package including:
Pay Scale:
$133,120 $166,400 ( Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.