Principal Scientist/Engineer I - Drug Product

Serve as a lead scientist/engineer on a given project/product, and contribute scientific insights into multiple other projects for oral dosage forms.  Assume technical ownership of a given product across the various stages of development and commercialization in coordination with other functional areas. Maintains product knowledge and serves as product focused subject matter expert. May direct research and/or project activities and professional development of a scientist(s) within the individual’s area of expertise, by effectively mentoring, guiding and/or supervising scientific personnel.

• Lead technical transfer and start-up of new solid dosage form processes while supporting the execution of lab- and plant-scale experiments.

• Lead CMC teams including tech transfers while establishing and reviewing complex plans for multiple projects ensuring appropriate resource allocation and distribution.

• Use statistical process control and other statistical tools for comparison and hypothesis testing.  Apply engineering, pharmaceutical sciences or materials sciences fundamentals to model the product and process to solve complex technical problems.   

• Recommend and evaluate experimental design options for complex technical problems with controls and consideration of error and variation.

• Demonstrate creative 'out of the box' thinking to solve difficult problems and champion new technologies to achieve project goals.

• Generate new scientific proposals and lead those efforts while identifying opportunities for cost reduction, cycle time and other process improvements.

• Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.

• Be the primary author of publications, presentations, regulatory documents and/or primary inventor of patents.

• Mentor/supervise a team of one or more and ensure high performing results from their team.

• BS or equivalent education in engineering/pharmaceutical sciences/material sciences and extensive, typically 14+ years of experience; OR MS or equivalent education with 12+ years of experience OR PhD with 6+ years of experience in area or scientific area of discipline.

• Experience in unit operations such as granulation, milling, compression, coating and/or extrusion processes for oral dosage form formulations including Amorphous Solid Dispersions and modified release products.

• Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies with a reputation for solving difficult technical problems and championing new technologies to achieve project goals.

• Recognized and sought out as an expert in his/her discipline within the company and possibly externally.

• Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.

• Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.

• Demonstrated knowledge of statistical process control, multivariate modelling and/or process modelling techniques.