Principal Scientist, Oral Formulation Scienes Full-time NEW

Pharmaceutical Sciences And Clinical Supply Scientist

Our company's Pharmaceutical Sciences and Clinical Supply (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:

• 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
• Mentors technical staff to develop team members scientifically and support the execution of pipeline programs
• 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
• Sets direction and coordinates technology development efforts in emerging drug delivery areas
• Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets
• Collaborates effectively within and across functional areas to lead the development of novel drug delivery technologies
• 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 chemistry, 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
• 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

Education Minimum Requirement:

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience.
• M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience.
• B.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 14 years relevant industrial experience.

Required Experience and Skills:

• Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process
• Ability to lead complex teams in the development of new molecules and new technologies that shape drug delivery strategy across our company
• Extensive experience with conventional and novel drug product technologies that can be utilized to develop pipeline assets, including hands on experience to independently operate in a pilot plant as well as an in-depth understanding of the science to train others in the department
• Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas
• Has broad knowledge of formulation science and in-depth knowledge in multiple areas, including core understanding of the drug development process, excipient attributes, and formulation-process interplay
• Demonstrated ability to independently design, execute and lead complex experiments and data analysis
• Track record of working effectively with team-members of diverse skill sets and backgrounds
• Strong verbal and written communication skills

Preferred Experience and Skills:

• Prior experience leading development projects at an enterprise level
• Strong mentoring capabilities to build individuals and teams
• Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technology
• Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.
• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
• Ability to engage others to build a strong scientific community and address drug delivery challenges.
• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems

Required Skills: Accountability, Adaptability, Animal Vaccination, Cell Culture Process Development, Cell Line Development, Chemical Biology, Chemical Physics, Combination Products, Data Analysis, Drug Development, Finite Element Analysis (FEA), Innovative Thinking, Leadership Mentoring, Manufacturing Processes, Materials Science, Mentorship, Organic Chemistry, Pharmaceutical Development, Pharmaceutical Process Development, Process Manufacturing, Professional Collaboration, Professional Networking, Project Development, Quality by Design {+ 5 more}

Preferred Skills: