Principal Scientist, Technical Director - Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

MSD•Rahway, NJ

1d•Onsite

About The Position

Job Description Job Description: 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. The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for a Principal Scientist / Sr. Principal Scientist / Technical Director – Process Engineering to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our Company's pipeline. The successful candidate will be a passionate engineer with strong academic fundamentals and a drive to develop and improve processes focusing on robustness to ensure the highest product quality. This individual will also be responsible for driving new technology strategy, scientific understanding and capability build within the organization. This person will: 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 Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence. Coordinate development and manufacturing activities with Oral Formulation Sciences, chemistry, analytical, and physical characterization groups Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence. 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 Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.

Requirements

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.

Nice To Haves

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 capabilities to build individuals and teams.

Responsibilities

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.
Coordinate development and manufacturing activities with Oral Formulation Sciences, chemistry, analytical, and physical characterization groups
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