CMC Technical Writer
Lab Support - San Diego, CA

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Our client, a growing biotechnology company, is looking for a Technical Writer to join their team.
Responsibilities

- Writing and review of protocols and/or reports for manufacturing process characterization studies
- Writing of protocols/batch records for manufacturing process validation
- Writing and/or review of other CMC documents as needed
- All activities will need to be performed in close collaboration with key team members

Skills/Experience:

- Excellent technical writing and reviewing skills for process development and manufacturing documents, including protocols and reports
- Ability to work within cross-functional teams in a multiple-priority, fast-paced environment is essential
- BLA writing experience a plus

All candidates need strong collaborative, interpersonal, and organizational skills

Qualifications:
· In depth technical experience in relevant biopharmaceutical development discipline
· 2 – 5 years regulatory writing experience
· 7+ years biopharmaceutical/biotechnology industry experience
· Ability to work independently with minimal direction to attain goals
· Demonstrated knowledge of the drug development process and government regulations/guidelines, including filing experience with US and international product registration
· Excellent communication skills
· Strong organizational skills, including the ability to prioritize personal workload
· Strong interpersonal skills and the ability to deal effectively with a variety of personnel including regulatory, scientific, and manufacturing staff
· Experience working simultaneously with multiple programs

Education:
Bachelors in Life Science degree (advanced degree preferred)

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