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Direct message the job poster from ACL Digital Senior Executive – US TAG at ACL (Pharmaceuticals, Life Sciences and Medical Devices) Job Title: CMC TW/Technical Duration: 06 Months Responsibilities 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. Seniority level Mid-Senior level Employment type Contract Job function Manufacturing Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr