Principal Scientist, Early Development Center of Excellence

Job Description Position Title: Principal Scientist, Early Development Center of Excellence Our company's Pharmaceutical Sciences and Device Development (PSDD) 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. Our Oral Formulation Sciences Early Development Center of Excellence is entrusted with developing and supplying our early development formulations, the team’s scope begins as a drug candidate exits discovery and extends through the creation of a Drug Product working group tasked with initiating Commercial Product Development. By cultivating deep technical expertise and applying entrepreneurship in early problem-solving, this center champions execution excellence and builds seamless enterprise collaboration with our partners throughout the enterprise. 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 a team of formulators responsible for the advancement of oral early development formulations. 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. Manages and mentors technical staff to develop team members and support the execution of pipeline programs. Ability to spearhead Due Diligence of potential pipeline assets and drug delivery technologies, including representing PSDD 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 while also helping to coach others in a collaborative environment. Coordinates development activities with chemistry, analytical, and physical characterization groups. Leads project activities at external manufacturing sites. Facilitates manufacturing, packaging and release of clinical supplies for clinical studies, assists in scale up activities at pilot scale, and summarizes results in technical reports and presentations. Enhances 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. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Company & Co., Inc., Rahway, New Jersey, USA is known as “Our Company” in the United States, Canada & Puerto Rico. We are known as “Our Company” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. 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