CMC Technical Writer at R&D Partners Los Angeles, CA

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

CMC Technical Writer job at R&D Partners. Los Angeles, CA.

Job Description

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:

• Medical insurance PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

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.

Job Requirements