The successful candidate will be a self-motivated scientist with an outstanding scientific track-record and extensive experience in pharmaceutical product development from the drug discovery interface through commercialization of oral drug product manufacturing.
Additional responsibilities are as follows:
Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis
Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets
Collaborates 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 results
Can independently execute formulation and process development activities using DOEs for new chemical entities or life cycle management opportunities while also helping to coach others in a collaborative environment
Coordinate development activities with process chemistry, preformulation, 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
Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others
Education Minimum Requirement:
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry 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**:
Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process
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
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
Capable of mentoring individuals in a peer to peer fashion and as a technical mentor
Recognized as a subject matter expert in at least one 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.
Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems
Internal Number: R6677
Pharmaceutical Sciences & Global Clinical Supply (Pharm. Sci. &GCS) undertakes a wide range of drug development activities to transform scientific concepts into innovative pharmaceutical products.
Pharm. Sci. & GCS are two Merck Research Laboratories (MRL) organizations that are passionately committed to setting the standard for our industry at multiple levels, including: 1) executing innovative and efficient pharmaceutical development, thereby maximizing patient value; 2) developing robust formulations, processes, and analytical methods to support commercialization of our products; 3) operating an agile, responsive, reliable, and cost-effective clinical supply chain; and 4) creating corporate value through product life cycle management (LCM) and intellectual property development.