Technical Writer - III

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.