Process Development Principal Scientist
Within Amgen's Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Cambridge, MA, is seeking an enthusiastic, highly motivated, and team-oriented scientist for the position of Process Development Principal Scientist. SET is a key Drug Product Technology interface with partners in Process Development, and, Research and Discovery. The Principal Scientist will provide scientific, technical and managerial leadership in support of SET's key responsibilities which include:
*Enabling lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).
*Solid state characterization support for drug substance and drug product process development for synthetics and biologics programs.
*Synthetics molecule assessment (developability assessment) and preclinical formulation support.
*Biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.
*Early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).
Reporting to the Director of Synthetics Enabling Technologies, the Principal Scientist will manage a team of scientists and associates, and, contribute to the strategic direction of the group based on industry trends, future requirements and feedback from key partners. This individual will focus on solid state characterization methods, physicochemical characterization, and/or material sciences, and will take a proactive role in developing and applying new solid state and material characterization approaches.
*Leads a high performing technical team with diverse scientific disciplines.
*Will effectively interface with partners in Process Development, and Research and Development to ensure optimum alignment between lead optimization, candidate selection, pre-pivotal activities and pivotal development requirements.
*Takes a proactive role in developing and applying new solid state and material characterization approaches, demonstrating creativity in solving complex technical problems, for example understanding excipient-drug interactions at the molecular level.
*Participate in, and help guide team members, managing molecule assessment, preclinical and early formulation development activities.
*Organize and leverage resources to maximize output while still being very innovative.
*Build and maintains strong working relationships with relevant internal and external customers and partners.
*Guide and mentor others on day to day performance, long term career development and through change.
*Regularly interacts with senior management and executives to create broad-based product formulation and combination product direction.
*Executes with a sense of purpose and drives course corrections where appropriate.
*Contributes to regulatory filings including IND and NDA; as needed assists in answering questions from regulatory authorities.
*Support rigorous review of department scientific and regulatory deliverables.
Doctorate degree and 3 years of Scientific experience
Master's degree and 6 years of Scientific experience
Bachelor's degree and 8 years of scientific experience
*Doctorate Degree in one of the following areas: Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Organic Chemistry, Physical Chemistry, Biochemistry, Protein Chemistry, or a related scientific discipline.
*8 years of solid state characterization, form screening, and/or material sciences experience with successful track record (including peer-review journal publications).
*Relevant preclinical and early clinical formulation and drug product development experience within a major biopharmaceutical or big pharmaceutical organization is a strong asset.
*Established knowledge of applicable global regulatory requirements and Experience preparing technical sections of regulatory submissions.
*Experience utilizing computational predictive tools for biopharmaceutical and physicochemical assessment (i.e. GastroPlus, Materials Studio, or related programs) is a plus.
*Knowledge of drug chemical stability assessment and mitigation strategies is an asset.
*Knowledge of automated screening platforms and strategies is highly beneficial.
*Strong focus on coaching, motivating and providing career and scientific/technical advice to staff.
*Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements.