Associate Principal Scientist, Oral Formulation Sciences, PSCS

Job Description

Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.

The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for leading the formulation development of new chemical entities as part of a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment.

Primary Responsibilities:

• Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis

• Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets

• Collaborates effectively within and across functional areas and is a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology.

• The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results

• Can independently execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities while also helping to coach others in a collaborative environment

• Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups

• Leads project activities at external manufacturing sites

• Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations

• Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations

• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

Education Minimum Requirement:

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant drug product development experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience.

Required Experience and Skills:

• Prior experience leading formulation development (Lead …