PROCESS DEVELOPMENT SPECIALIST
Seeking a Process Development Specialist that have a statistical background. THE PROCESS DEVELOPMENT SPECIALIST MUST POSSESS REGULATORY EXPERIENCE IN THE PHARMACEUTICAL, BIOTECHNOLOGY OR MEDICAL DEVICES INDUSTRY.
Skills and Qualifications
- Conceives and designs, executes or evaluates, and interprets experimental strategies.
- Provides input to new processes to generate robust and reliable data.
- Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
- Provides data analysis and interpretation and assesses impact of the data on the project.
- Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
- Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
- KNOWLEDGE IN FILLING PROCESS
- KNOWLEDGE IN GRANULATION AND COMPRESSION OF SOLID DOSAGE
- KNOWLEDGE IN PARENTERAL FORMULATION
- EXPERIENCE WITH MINITAB
- Basic Project Management
- Problem solving skills
- Negotiation, persuasion, facilitation and project cost development skills.
- Manage multiple tasks
- Able to work independently
- Strong oral and written communication skills.
- Fully bilingual (English and Spanish)
- Facilitates and organizes
- Microsoft Office
Bachelor's degree and 5 years of experience
. RELATED EXPERIENCE IN THE PHARMACEUTICAL, BIOTECHNOLOGY OR MEDICAL DEVICES INDUSTRY
Integrated Technology and Compliance Services is an Equal Opportunity Employer