Pharmalucence is an Equal Opportunity Employer
- Formulation Chemist
- Analytical Development Scientist
- Principal Process Development Scientist
- Sr. QA Specialist
- Document and Records Management Supervisor
Plan, assess and execute the formulation and dispensing of simple, moderate and complex pharmaceutical product according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment.
Responsibilities and Tasks
Knowledge Skills and Abilities
- Work with Development scientists to execute the technical transfer of complex product specifications during technology transfer from laboratory to production.
- Formulate and dispense complex product in a clean room environment.
- Function as scientific specialist in Production and provide technical support and training to Production team members and other departments.
- D ocument data and review completed batch records to ensure product is made in accordance with specifications
- Perform investigations and solve moderate to complex problems related to the product, process and transfer of new and existing products.
- Assist in Batch Record and SOP review
- Draft and track CAPAs, deviations and DCRs as required.
- Complete all required paperwork to conform with FDA regulations
- Follow all company policies relating to job safety
- A strong understanding of and formal training in cGMP and GLP
- Proficiency in aseptic fill/finish, formulation techniques
- Strong experience working in a controlled environment
- Strong experience working in pharmaceutical environment
- Excellent computer skills including complex scientific applications
- Team player with excellent verbal, written and interpersonal skills
- Ability to work under minimal supervision and organize diverse workload
Education and Experience
- Requires BS in Chemistry or other related scientific major or AS with equivalent experience
- Minimum 4-6 years related pharmaceutical manufacturing work experience