R&D Partners
CMC Technical Writer at R&D Partners Los Angeles, CA
R&D Partners, Los Angeles, California, United States, 90079
Job Description
R&D Partners is seeking to hire a
CMC Technical Writer/Technical Role
in
Santa Monica, CA . Overview
CMC Technical Writer/Technical Role with responsibilities including authoring and finalizing regulatory documents in collaboration with Regulatory CMC and Technical Subject Matter Experts. Responsibilities
Author and finalize appropriate Module 3 documents and responses to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts. Qualifications
Bachelor\'s, Master\'s, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelor\'s), 5+ years (Master\'s), 3+ years (PhD) of relevant experience. Experience with CMC/Module 3 regulatory submissions. Experience in technical writing and producing high-quality written documents. 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. Benefits
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
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 #J-18808-Ljbffr
R&D Partners is seeking to hire a
CMC Technical Writer/Technical Role
in
Santa Monica, CA . Overview
CMC Technical Writer/Technical Role with responsibilities including authoring and finalizing regulatory documents in collaboration with Regulatory CMC and Technical Subject Matter Experts. Responsibilities
Author and finalize appropriate Module 3 documents and responses to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts. Qualifications
Bachelor\'s, Master\'s, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelor\'s), 5+ years (Master\'s), 3+ years (PhD) of relevant experience. Experience with CMC/Module 3 regulatory submissions. Experience in technical writing and producing high-quality written documents. 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. Benefits
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
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 #J-18808-Ljbffr