The RND- Technical Writer/Scientist I is responsible for creating new protocols, revising process validation protocols, manufacturing batch records and technical reports in accordance with site SOP’s. A technical writer will be responsible for preparing the development /validation/ investigation report with appropriate conclusions and recommendations under supervision. A Scientist I will work on the development/scale-up trials /technical transfer projects. They will also work cross functional with subject matter experts, operation, and quality as and when required.
Direct Report to the Senior Director, R&D/Technical Services
• Generate and execute all process characterization/validation protocols of all site transfer project to HPL in an FDA regulated environment
• Technical writing and review of product development/validation reports, justification reports and FDA Deficiency Response for filed ANDAs.
• Preparing Master manufacturing batch records, process characterization/validation protocols, cleaning verification/validation protocols.
• Prepare process validation and cleaning validation reports at the conclusion of validation studies.
• Analyze validation results and compile data into summary reports.
• Writes and manages department SOP’s, training etc. to ensure regulatory compliance and operations enhancement. Responsible for site transfer and technology transfer of new products.
• Transfer of technology for new products from R&D or other sites to the manufacturing site.
• Coordinate development activities for each drug product with the respective departments.
• Work proactively with QA, Manufacturing, and other groups and coordinate/manage manufacture of registration/bio, validation, and initial commercial batches.
Special Skills and Knowledge:
B.S. in Pharmacy, Chemistry or Chemical Engineering or other scientific discipline plus a minimum of 4 years’ experience.
Math skills plus knowledge of statistical methods and basic chemistry.
- Computer skills including Word Processing, databases, and spreadsheets.
- Knowledge of cGMP and basic regulatory requirements.
- Use of statistical methodologies
1. Hands-on technical writing, formulation research and development as well as formulation scale-up experience is desired, knowledge of US FDA registration guidelines.
2. Good team player and self-starter, innovative and comfortable in a multi-disciplinary team under defined timelines.
Roles with moderate physical demands: While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs
At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.
Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.