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Title: CMC Technical Writer Location: Santa Monica, CA Duration: 06 months 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 and in this role, this individual will be supporting the internal Process Development teams. In the near-term, this role will support time critical CMC Regulatory submissions. Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects. Responsibilities (include but are not limited to): • 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. Requirements: • 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 • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing • Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Writing/Editing Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at ACL Digital by 2x Get notified about new Technical Writer jobs in
Santa Monica, CA . Associate Tech Editor and Writer / Tech Editor and Writer (AHT) - R10202000
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California, United States $70.00-$80.00 22 hours ago Universal City, CA $48.00-$55.00 1 day ago Carson, CA $75,000.00-$110,000.00 2 weeks ago United States $75.00-$82.00 15 minutes ago Santa Monica, CA $160,000.00-$166,000.00 23 hours ago Santa Monica, CA $80.00-$85.00 23 hours ago Santa Monica, CA $80.00-$85.00 21 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Title: CMC Technical Writer Location: Santa Monica, CA Duration: 06 months 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 and in this role, this individual will be supporting the internal Process Development teams. In the near-term, this role will support time critical CMC Regulatory submissions. Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects. Responsibilities (include but are not limited to): • 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. Requirements: • 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 • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing • Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Writing/Editing Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at ACL Digital by 2x Get notified about new Technical Writer jobs in
Santa Monica, CA . Associate Tech Editor and Writer / Tech Editor and Writer (AHT) - R10202000
Redondo Beach, CA $55,600.00-$100,700.00 2 weeks ago Technical Author (multiple roles and seniority levels)
Culver City, CA $110,000.00-$118,000.00 3 weeks ago Long Beach, CA $75,000.00-$95,000.00 2 days ago Carson, CA $75,000.00-$110,000.00 2 weeks ago Technical Writer (pharmaceutical, CMC, QA/QC)
California, United States $70.00-$80.00 22 hours ago Universal City, CA $48.00-$55.00 1 day ago Carson, CA $75,000.00-$110,000.00 2 weeks ago United States $75.00-$82.00 15 minutes ago Santa Monica, CA $160,000.00-$166,000.00 23 hours ago Santa Monica, CA $80.00-$85.00 23 hours ago Santa Monica, CA $80.00-$85.00 21 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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