Fladger Associates

Compensation

Full Description

Responsibilities: Excellent employment opportunity for a Technical Writer - III in the Santa Monica, CA area.Contractor Role JD: CMC TW/Technical RoleSeeking 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 ExpertsExperience 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 experienceExperience CMC/Module 3 regulatory submissionsExperience in technical writing and proficient in high quality writingDemonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process developmentThorough knowledge of biologics analytical and process development is essential.Cell therapy process development experience is highly desiredKnowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturingWorking knowledge of regulatory requirements for biologics, pharmaceuticals and medical devicesMust be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisionsAbility to think critically, and demonstrated troubleshooting and problem solving skillsSelf-motivated and willing to accept temporary responsibilities outside of initial job descriptionWell-developed computer skills and fluent with Microsoft office applicationsExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentComfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities