Principal Scientist, Technical Director - Process Engineering - Oral Solid Dosage, Clinical Man

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. This team ensures right-first-time manufacture and delivery of high quality non-sterile drug products (spray-dried intermediates, tablets and capsules) leveraging unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our company's research division, focusing on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials.

• Own FLEx interactions across CMC project teams, and especially the manufacturability assessment of first-in-human formulations (suspensions, solutions, capsules, tablets) to final market formulation, defining scaling and control strategies in partnership with Oral Formulation Sciences and Pharmaceutical Commercialization Technologies, among other teams.
• Lead development of new, innovative approaches for product and process development, generation of experimental designs, and data analysis to impact pipeline development and set strategic direction.
• Mentor a team of process engineers to develop team members scientifically and support the execution of pipeline programs.
• Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.
• Bring knowledge and creativity to the position as well as having the discipline to drive results.
• Coordinate development and manufacturing activities with Oral Formulation Sciences, chemistry, analytical, and physical characterization groups.
• Enhance the 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.

• Extensive knowledge, experience and proven expertise in GMP drug product processing, particularly in solid oral dosage forms, leading on-the-floor activities, process robustness & validation, root cause analysis, change control, and deviation management.
• Recognized as a subject matter expert and scientific contributor in multiple drug deliveries and/or manufacturing technologies.
• Established record of high-impact contributions and/or interactions with publications, advisory seats, industry-university consortia participation, or others.
• Proven track record in operating in a fast-paced manufacturing environment to resolve technical issues while meeting customer needs in a compliant manner.
• Demonstrated capability in leading and coaching others with strong coordination, communication, and supervision on all technical issues.
• Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.
• Experience supporting GMP audits, responding to observations, and owning CAPAs that comprehensively address opportunity areas.
• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, engineering, and materials science to solve practical pharmaceutical problems.
• Breadth and depth of experience in related functional areas, including Formulation, Analytical Sciences, and Commercialization.
• Ability to lead process development activities in matrix team environments to define a robust manufacturing process for traditional and/or unconventional formulations.
• 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.

Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum of 14 years relevant experience, or a Master’s degree with 10 years of relevant experience, or a PhD degree with 8 years of relevant experience.

• Extensive hands-on experience with conventional and novel drug product technologies that can be utilized to develop pipeline assets, including in-depth understanding of the scientific principles behind them.
• Has 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 understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and commercial marketing, balancing the needs of patients and ensuring successful launch of drug products.
• Experience leading development projects at an enterprise level.
• Strong mentoring…