Technical Writer

1 day ago Be among the first 25 applicants Client is 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): 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. Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts Requirements: Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, 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 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 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 Seniority level

Seniority level Mid-Senior level Employment type

Employment type Contract Job function

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