Associate Principal Scientist, External Capabilities
PharmaBiotechCROClinical ResearchRegulatory AffairsQuality Assuranceemacrorave
Job description
Job Description The Associate Principal Scientist reports into the External Capabilities group within Small Molecule Process Research & Development. The successful candidate will be responsible for providing scientific leadership and oversight for teams of scientists at our external partners. The role provides regular scientific direction and timely problem-solving in the areas of synthetic route design, route scouting, process optimization and development, and active pharmaceutical ingredient, API, delivery in support of the Company’s small-molecule pipeline. The incumbent collaborates effectively with Process Chemistry, Discovery Process Chemistry, Enabling Technologies, Chemical Engineering Research & Development, Analytical Research & Development, Quality, and other partner groups to develop innovative and practical solutions to synthetic chemistry and process-development challenges. The individual will work across internal and external teams to help ensure successful API deliveries under demanding project timelines. The position requires strong subject-matter expertise in synthetic organic chemistry and broad knowledge of pharmaceutical development. The incumbent is expected to apply sound scientific judgment, identify and manage technical risks, and influence project teams through data-driven recommendations and effective problem-solving. As a scientific contributor and project leader within Small Molecule Process Research & Development, the incumbent is expected to build a broad internal network, contribute technically and strategically across a portfolio of programs, and support the scientific development of colleagues within the organization. The individual may mentor less-experienced scientists and contribute to functional or cross-functional scientific initiatives. The Associate Principal Scientist builds and maintains strong working relationships with scientists and management at strategic external partners. The incumbent promotes a culture of scientific excellence, trust, collaboration, quality, safety, and compliance across Company and partner teams. Strong communication, negotiation, influencing, and relationship-management skills are essential for establishing effective partnerships across diverse geographies and cultures. The successful candidate must be able to communicate technical expectations clearly, constructively challenge scientific proposals, align stakeholders, and drive external teams toward high-quality and timely outcomes. Primary Responsibilities Provide scientific leadership and day-to-day technical oversight for process chemistry activities conducted at external partners. Guide synthetic route design, route scouting, process optimization, reaction understanding, impurity-control strategy, process robustness, and preparation of intermediates and APIs. Serve as a key scientific interface between external partners and internal project teams, ensuring that technical priorities, deliverables, risks, and timelines are clearly understood. Critically evaluate experimental plans, data packages, development reports, and technical proposals from external partners. Identify emerging scientific, operational, quality, and delivery risks, and work with internal and external stakeholders to establish practical mitigation plans. Apply innovative and rigorous problem-solving approaches to complex synthetic chemistry and process-development challenges. Collaborate with Process Chemistry, Discovery Process Chemistry, Enabling Technologies, Chemical Engineering Research & Development, Analytical Research & Development, Quality, and other partner functions to advance programs and support successful API delivery. Contribute to technical and strategic decisions for assigned projects or a portfolio of programs through clear, data-based recommendations. Establish productive relationships with scientists and management at external partner organizations and promote transparent communication and timely issue escalation. Support effective knowledge transfer between external partners and internal project teams. Promote high standards of scientific rigor, documentation, quality, data integrity, safety, and compliance across external activities. Contribute to the development and implementation of external capability strategies, working practices, scientific standards, and continuous-improvement initiatives. Mentor and support the scientific development of colleagues and external-partner scientists, as appropriate. Communicate project progress, technical risks, key decisions, and recommended actions clearly to scientific and cross-functional stakeholders. Qualifications Education Requirement Ph.D. in synthetic organic chemistry or a closely related field. Required Experience and Skills Relevant pharmaceutical or biotechnology industry experience in synthetic chemistry, process chemistry, or closely related drug-development activities. Demonstrated ability to independently lead complex scientific activities and effectively guide multidisciplinary or external project teams. Strong knowledge of synthetic organic chemistry, route design, process development, reaction optimization, impurity control, and scale-up considerations. Demonstrated record of delivering high-quality scientific results through innovation, sound judgment, and proactive problem-solving. Ability to critically analyze complex experimental data, identify technical risks, and recommend practical development strategies. Experience collaborating across scientific and operational functions to achieve project objectives and delivery commitments. Strong interpersonal, written, and verbal communication skills. Effective negotiation, influencing, collaboration, and relationship-management skills. Ability to work effectively across organizational boundaries, cultures, geographies, and time zones. Demonstrated commitment to scientific excellence, data integrity, quality, safety, compliance, and ethical decision-making. Evidence of scientific contribution through publications, presentations, patents, internal technical reports, process-development accomplishments, or other relevant forms of scientific impact. Ability and willingness to travel approximately 25% of the time , based on business needs. Preferred Experience Experience providing scientific oversight for work performed at contract development and manufacturing organizations or other external research and development partners. Experience with synthetic route development and process scale-up from laboratory studies through multikilogram or manufacturing-scale execution. Experience supporting API deliveries across one or more stages of pharmaceutical development. Familiarity with technology transfer, external manufacturing, analytical control strategies, process safety, quality systems, and regulatory expectations relevant to pharmaceutical development. Experience working on multiple projects or programs with competing technical priorities and timelines. Experience mentoring scientists or providing technical guidance to project teams. Demonstrated ability to establish effective working relationships with external scientists, project leaders, and partner-site management.</
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