The Product Development Specialist will work in collaboration with the New Product Development Lead to research drug formulations, generate product data, convert data into reports and presentations distribution to management. In addition, this person will participate in the monitoring of ongoing studies and the termination of completed studies. At times, this person will work with the operations department to review, develop, and enhance manufacturing processes. Supplementary tasks will include interacting with production and quality groups to ensure new products can be manufactured to meet customer requirements and standards.
Activities include, but are not limited to:
- Creation and Execution of Protocols
- Drafting of Standard Operating Procedures
- Creation of Batch Records and Support Documentation
- Editing of Technical Documents (Batch Records, Standard Operating Procedures, Protocols, Reports)
- Researching Drug Formulations
- Authoring and Editing Reports for Product Release
- Convert Raw Data for Data Analytics
- Communicating with Internal and External Laboratories
- Interpretation and Application of Regulatory Guidance as Applicable to The Pharmaceutical Industry (FDA, ICH, CFR, etc.)
- Bachelor of Science Degree in Biology, Chemistry, Engineering, Or Related Scientific Field
- Expertise in Technical Writing: Controlled Documents, Training Materials, Investigations, CAPAs Or Similar
- Experience with Researching Drug Formulations
- Experience Reading and Drafting Technical Writing
- Experience in Data Analytics
- Proficient in Good Documentation Processes
- Drug Manufacturing Experience Is Preferred
- Experience with process engineering particularly the development, evaluation, and improvement of manufacturing methods.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.