CMC Technical Writer — Biotech Regulatory Submissions

R&D Partners; Los Angeles (CA); On-site; USD 133,120 - 166,400; Full time

Benefits offered by this job

Medical insurance PPO, HMO & HSA

Dental & Vision insurance

401k plan

Employee Assistance Program

Job summary

R&D Partners is seeking a CMC Technical Writer/Technical Role to author and finalize Module 3 documents and respond to agency questions in collaboration with Regulatory CMC and SMEs.

Ideal candidates possess 7+ years (Bachelor), 5+ years (Master), or 3+ years (PhD) in relevant fields, with experience in CMC regulatory submissions and strong technical writing. Biologics analytics and process development knowledge is essential.

Qualifications

• 7+ years (Bachelor) / 5+ years (Master) / 3+ years (PhD) of relevant experience
• Experience CMC/Module 3 regulatory submissions
• Experience in technical writing with high-quality output
• Knowledge of pharmaceutical manufacturing of biotech products
• Cell therapy process development experience is highly desirable

Responsibilities

• Author and finalize Module 3 documents and responses to agency questions
• Collaborate with Regulatory CMC and subject matter experts
• Demonstrate knowledge of biologics analytical and process development
• Support regulatory submissions and ensure compliant documentation

Skills

Technical writing

CMC knowledge

Regulatory submissions

Pharmaceutical manufacturing knowledge

Vector/T cell knowledge

Education

Bachelor's degree in Biochemical Engineering

Master's degree in Biochemical/ Biomedical Engineering

PhD in Biochemical/Biotechnology related field

Job description

R&D Partners is seeking a CMC Technical Writer/Technical Role to author and finalize Module 3 documents and respond to agency questions in collaboration with Regulatory CMC and SMEs.

Ideal candidates possess 7+ years (Bachelor), 5+ years (Master), or 3+ years (PhD) in relevant fields, with experience in CMC regulatory submissions and strong technical writing. Biologics analytics and process development knowledge is essential.