JOB OBJECTIVE: Work with Manufacturing, Process Development, Engineering and R&D as requested to design and scale-up robust product formulations and equipment from laboratory scale to production scale. Work with R&D to enhance guidelines for ideal formulations for liquid products. Assist Manufacturing in problem solving with regards to product stability (temperature, light, and vibration sensitivities, etc.). Participate in the design and scale-up of new formulation processes including technology transfer, and process-validation activities. Ensure that formulation processes and designs will deliver expected product quality. The Formulation Development Scientist is also a key contributor regarding selection of new final product formulation technologies, processes and equipment to broaden the range of final product format options. In addition to liquid formulations, this role will be heavily focused on increasing the flexibility of lyophilization processes.
1. Work with Production Scientists, Engineering, and R&D as requested to develop new and improved formulation processes for product manufacturing. Determine the business case to support new formulation processes and equipment.
2. Perform screens for potential final product formulations and formats.
3. Coordinate cross-departmentally to identify, prioritize and implement formulation process improvement plans for manufacturing of specified products.
4. Independently design stability studies and experiments to understand critical control parameters to optimize various formulations.
5. Collaborate on formulation development and stability experiments which may include (but not limited to) lyophilization, and liquid formulations as requested.
6. Identify, evaluate, develop, and implement various product format options to achieve increased flexibility in product offerings and increased shelf life stability in final package format.
7. Utilize interactions with internal and external resources to improve and enhance efficiencies and effectiveness of product formulations. Prepare and deliver project status presentations to customer groups and Promega Management as needed.
8. Assist in nonconformance investigations.
9. Assist with CAPA Investigations that have the potential to significantly improve product stability.
10. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
11. Stay up-to-date on current and up-and-coming technologies regarding product formulations.
1. Participate in process and/or equipment validation activities.
2. Present updates and departmental information at various company meetings.
1. Masters or PhD in Bioengineering, Bioprocess Engineering, Biotechnology, Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field with at least 3 years of applicable industry experience.
2. Demonstrated experience in the development of non-traditional drying or lyophilization processes.
3. Solid computer skills and working knowledge of Word, Excel, and PowerPoint.
4. Demonstrated experience managing complex projects with little daily instruction and receiving only general instruction/vision on new projects/assignments.
5. Demonstrated record of achievement in a laboratory or manufacturing environment including troubleshooting issues with complex biological processes or products.
6. Excellent organization, communication, and presentation skills.
1. 5 or more years’ experience in manufacturing processes preferably in a cGMP/FDA regulated industry.
2. 5 or more years’ experience in use of processes such as Lean Manufacturing, Six Sigma, FMEA, DOE, etc.
3. PhD in a scientific discipline.
4. Demonstrated experience with process scale-up/scale-down.
1. Ability to work in a production environment around automated equipment.
2. Ability to work in an office environment utilizing a computer workstation.
3. Ability to work in a lab environment with chemical, biological, and packaging materials.
4. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.