Job Title: CMC TW/Technical

Location: Santa Monica CA/Hybrid

Duration: 06 Months

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