Investigates, creates, and validates new scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations. Participates in technical discussions with clients with a high level of technical proficiency. Engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with independent judgement. Typically works in a specific scientific area, such as analytical development, cell culture, purification, process validation, formulations, and/or manufacturing technical support. Makes decisions that require developing new options to solve complex problems.
1. Participates in development of scientific strategy.
2. Develops realistic proposals and timelines. Leads meetings/teleconferences with clients.
3. Coordinates development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
4. Coordinates research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients.
5. Leads projects without supervision; may lead multiple projects, including managing project timelines and deliverables.
6. Guides and advises during implementation of new methodologies and processes.
7. Analyze and solves problems related to the conduct of chemical experiments.
8. Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
9. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
10. Maintains the necessary compliance status required by company and facility standards.
Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science. Advanced degree preferred.
At least 8 years of progressive scientific experience, including 5 years in product life-cycle of oral solid dosage.
- Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
- Thorough knowledge of Good Manufacturing Practices.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Ability to work on multiple projects simultaneously.
- Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
- Ability to keep current with scientific literature and industry trends relating to process technologies.
- Ability to develop technical solutions.