What are the responsibilities and job description for the Principal Scientist, Oral Formulation Sciences, PSCS position at Merck Sharp & Dohme (MSD)?
## Job Description
Our company's Pharmaceutical Sciences and Clinical Supplies (PSCS) 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 CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization.
### Primary Responsibilities:
1. Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction
2. Mentors technical staff to develop team members scientifically and support the execution of pipeline programs
3. Ability to spearhead Due Diligence of potential pipeline assets and drug delivery technologies, including representing PSCS on cross-functional teams to make strategic and technical recommendations to leadership
4. Sets direction and coordinates technology development efforts in emerging drug delivery areas
5. Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets
6. Collaborates effectively within and across functional areas to lead the development of novel drug delivery technologies
7. Is a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology
8. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results
9. 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
10. Coordinate development activities with process chemistry, material biopharmaceutics, analytical, and physical characterization groups
11. Leads project activities at external manufacturing sites
12. 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
13. 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
14. Builds and maintains awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and develop staff across the organization
Our company's Pharmaceutical Sciences and Clinical Supplies (PSCS) 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 CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization.
### Primary Responsibilities:
1. Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction
2. Mentors technical staff to develop team members scientifically and support the execution of pipeline programs
3. Ability to spearhead Due Diligence of potential pipeline assets and drug delivery technologies, including representing PSCS on cross-functional teams to make strategic and technical recommendations to leadership
4. Sets direction and coordinates technology development efforts in emerging drug delivery areas
5. Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets
6. Collaborates effectively within and across functional areas to lead the development of novel drug delivery technologies
7. Is a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology
8. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results
9. 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
10. Coordinate development activities with process chemistry, material biopharmaceutics, analytical, and physical characterization groups
11. Leads project activities at external manufacturing sites
12. 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
13. 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
14. Builds and maintains awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and develop staff across the organization
