Technical Writer Formulation
$72,114–$72,114 year
On-site · East Brunswick, New Jersey, United States
Job Summary
Technical Writer/Formulation responsible for creating and revising protocols, manufacturing batch records, and technical reports in an FDA-regulated environment; prepares development/validation/investigation reports with conclusions and recommendations under supervision; coordinates development activities for drug products with QA, Manufacturing, and other groups; transfers technology from R&D or other sites to the manufacturing site; writes and manages SOPs and training to ensure regulatory compliance and operational enhancement; supports site transfer and technology transfer of new products and conducts cross-functional collaboration to generate process characterization/validation protocols and validation reports; prepares master manufacturing batch records and validation/cleaning validation reports; analyzes validation results and compiles data into summary reports; requires BS degree and strong technical writing, regulatory knowledge, and multi-disciplinary collaboration.
Required Qualifications
- B.S. in Pharmacy, Chemistry or Chemical Engineering or other scientific discipline
- Math skills plus basic knowledge of statistical methodology and chemistry
- Computer skills including Word Processing, databases and spreadsheets
- Knowledge of cGMP and basic regulatory requirements
- Use of statistical methodologies
- Hands-on technical writing, formulation research and development as well as formulation scale-up experience is desired, knowledge of US FDA registration guidelines
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