Responsible for performing a wide variety of hands-on analytical work to support the successful development and commercialization of pharmaceutical nasal spray drug products.
- Conduct testing of raw materials and components, in-process and finished product samples per standard operating procedures.
- Perform peer review of documentation for accuracy, compliance to SOPs and completeness.
- Lead stability sample coordination and testing work for multiple drug products
- Lead analytical projects or participate on teams to develop and commercialize products.
- Assist with the performance of formulation development studies and the transfer of analytical methods from outside sites.
- Write technical reports related to assigned work.
- Coordination with Materials Management for procuring excipients, drug substances and components for coordination and completion of the testing.
- Identify and implement methods for cost savings, improved efficiency and control.
- Assist management with training and guiding of technicians for the execution of sample analysis and protocols.
The individual must have experience in an FDA regulated cGMP laboratory environment. Additionally, the Chemist possesses:
- Excellent organizational skills and attention to detail.
- Strong interpersonal and communication skills and demonstrated ability to effectively communicate with all departments.
- Motivated to perform work while maintaining a focus on the long-term, continuous improvement of laboratory systems, compliance and training programs.
- Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
- Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
- Experience testing nasal spray products is a plus.
- BS in Chemistry, Biochemistry or related field
- 5 years of applicable experience working in a pharmaceutical laboratory
- Hands on experience with analytical laboratory instrumentation including HPLC
- In depth knowledge of cGMP regulatory requirements
- Excellent technical writing and organizational skills
- Qualified to handle controlled substances
- Good interpersonal skills and the ability to work well in a team environment