Job Description
Our company's Pharmaceutical Sciences & Clinical Supplies 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 the formulation development of new chemical entities as part of a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment.
Primary Responsibilities:
Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysisDrives evaluation of new technologies and leads capability build to deploy them to pipeline assetsCollaborates effectively within and across functional areas and 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 resultsCan 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 environmentCoordinate development activities with process chemistry, preformulation, analytical, and physical characterization groupsLeads project activities at external manufacturing sitesFacilitate 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 presentationsEnhance 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 innovationsMaintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with othersEducation Minimum Requirement:
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant drug product development experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience.Required Experience and Skills:
Prior experience leading formulation development (Lead Formulator) activities in matrix team environments to define a robust formulation and manufacturing processExperience 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 departmentScientific contributor with proven ability to identify and develop innovative ideasHas broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development processDemonstrated ability to independently design, execute and lead complex experiments and data analysisTrack record of working effectively with team-members of diverse skill sets and backgroundsStrong verbal and written communication skillsPreferred Experience and Skills:
Prior experience leading development projects at an enterprise levelCapable of mentoring individuals in a peer to peer fashion and as a technical mentorRecognized as a subject matter expert in at least one drug delivery and/or manufacturing technologyDemonstrated 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.Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problemsBreadth of experience in related functional areas, including: Pharmaceutical Operations, Analytical Sciences, and Commercialization#J-18808-Ljbffr
