Job Description
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Job Title : CMC Technical Writer ( in QA, Viva/LIMS, pharmaceutical )
Job Location: Santa Monica, California Remote role
Job Duration: 6 months; May extend
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
Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
Ability to think critically, and demonstrated troubleshooting and problem solving skills
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Well-developed computer skills and fluent with Microsoft office applications
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
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