CMC Technical Writer - Fladger Associates : Job Details

Responsibilities:

• Excellent employment opportunity for a Technical Writer - III in the Santa Monica, CA area.
• Contractor Role JD: CMC TW/Technical Role
• 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.
• 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.

Experience:

• Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical 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