Summary
In this role, the Process Associate Scientist I/II will involve developing and optimizing pharmaceutical manufacturing processes, ensuring product quality and consistency, and complying with regulatory requirements on commercial formulations for orally inhaled and nasal drug products (OINDPs). Conducts pilot scale manufacturing activities including formulation and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. The individual will design and execute formulation experiments, organize and analyze results with minimal supervision, and communicate data and interpretation to product development team. Contribute towards the development of orally inhaled and nasal drug products (OINDPs) by following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
Essential Duties and Responsibilities
- Conducts standard and advanced laboratory activities including formulation development and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. Conducting research and development to improve manufacturing processes on automated filling and packaging equipment.
- Works independently to determine methods and techniques on new or difficult assignments related to research, formulation and process development and manufacturing activities.
- Working with regulatory agencies to ensure compliance with manufacturing standards.
- Troubleshooting manufacturing issues and identifying areas for process improvement.
- Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.
- Interfaces with Quality Assurance and Compliance, to ensure that work is being performed and documented according to established procedures.
- Plans and designs new testing methodologies to assess the performance of new product formulations.
- Contribute towards development of orally inhaled and nasal drug products (OINDPs) by following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
- Document and report all laboratory and manufacturing activities according to cGMPs and Transpire Bio’s SOPs.
- Work and communicate effectively with other functional groups and across global respiratory R&D sites.
- Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs; follow Transpire Bio safety rules and procedures.
- Comply with all Transpire Bio Corporate guidelines and policies.
Qualification Requirements
- Degree in Chemical/Biochemical Engineering, Chemistry, Biochemistry or a related scientific discipline and relevant industry experience that demonstrates an expertise in formulation process development.
- BS degree with 1-5 years’ experience or a MS degree with 0-3 years’ experience is required.
- Experience in the formulation, process development and/or manufacture of injectables, ophthalmic, other sterile products is preferred.
- The ability to embrace a highly multi-disciplinary collaborative approach and work independently is essential.
- Adaptable and flexible, readily adapts to change & new projects.
- Engineering/Science background with knowledge of product development processes
- Quick learner and ability to think critically
- Ability to pay special attention to detail with degree of accuracy.
- Excellent interpersonal, organizational and communication skills.
- Strong written and verbal communication skills are required.