Principal Engineer, Process Development - OSD

Overview In this role you will lead late-stage small molecule process development and technology transfer to manufacturing, guiding internal and external teams from Phase 3 through PPQ. You’ll work within the CMC and Operations ecosystem to drive decision-making in a collaborative matrix environment, shaping development programs and enabling the successful delivery of new drugs. You will translate science into scalable processes, identify new tech opportunities, and mentor junior staff. This is a high-impact, cross-functional role at a global biotech leader. Compensation / Benefitscompetitive benefits packagehybrid working modelonsite requirement in Waltham, MA 3 days/weekbase salary range $173,000–$193,000annual performance bonusopportunity to work in a leading neuroscience-focused biopharma ResponsibilitiesLead late-stage small molecule process development activities at internal and external manufacturing sitesProvide technical guidance and drive execution for process development, scale-up and tech transfer to manufacturing (Phase 3 to PPQ)Collaborate with CMC and Operations to support development goalsOversee external partner activities with CDMOs, ensuring timely technical support and quality deliverablesDevelop, review, and approve process development source documents; author/review regulatory submission sectionsPresent technical data to cross-functional teams and senior management; communicate critical process issues and solutionsIdentify and advocate for new technology opportunities in process developmentManage, train and mentor junior Process Development staffPerform other duties as assigned Key requirementsPhD in Science or Engineering with >8 years of experience or MS with >15 years of experience in relevant fieldExpertise in small molecule process development, scale-up and tech transferExperience managing CDMO activitiesStrong problem-solving using current research and technologiesBroad understanding of the drug development process and role of process developmentStrong communication skills (verbal and written)Expert understanding of ICH, FDA, and USP guidelines and applying them contextuallyProficiency in processing techniques: powder blending, granulation, compression, encapsulation, Wurster and pan coatingAbility to work in fast-paced, matrix environments and manage multiple prioritiesExperience with Process Analytical Technology (preferred)collaborative leadershipstrong verbal and written communicationrelationship-building across cross-functional teamsdesign of experimentsdata analysis and interpretationprocess development methodologies