Sr. Process Development Engineer - OSD

Overview In this role you will lead and support the development of robust oral solid dosage processes within a cross-functional team. You will design experiments, optimize manufacturing steps, and ensure GMP compliance in clinical and pilot-scale settings. You will drive process understanding, transfer knowledge to manufacturing, and improve reliability while reducing waste. This is a hands-on leadership role at the intersection of technology, quality, and project delivery, with a focus on advancing neuroscience-targeted medicines. Compensation / Benefitshybrid workplace modelonsite 3 days per weekannual performance pay bonuscompetitive benefits package ResponsibilitiesProvide technical leadership for oral solid dosage process development and scale-upDesign and execute experiments to deepen process knowledge and robustnessLead cross-functional initiatives with CMC, formulation, engineering, and QA teamsOversee lab-scale to pilot-scale development and GMP clinical manufacturingCreate and maintain batch records, change controls, and SOPsTroubleshoot equipment and optimize process designs to reduce waste and improve reliabilityEnsure compliance with cGMP, safety, and environmental regulationsAuthor CMC sections for IND/NDA filings and support regulatory documentationMentor junior staff and transfer knowledge to manufacturing teams Key requirementsPh.D. in engineering/scientific discipline with 3+ years of related pharmaceutical experienceExperience in oral solid dosage processing (milling, blending, granulation, compression, encapsulation, coating)Proven track record in small molecule process development, scale-up, and technology transferStrong collaboration, communication, and project management abilitiesKnowledge of ICH, FDA, and USP guidelines; experience with PAT/Process Analytical Technology preferredHands-on ability to install/troubleshoot instrumentation and equipmentExperience working in GMP environments and producing GMP batchescollaborative leadershipexcellent verbal and written communicationproblem-solving and data-driven decision makingoral solid dosage processing techniquesdesign of experiments (DOE) and data interpretationGMP and regulatory compliance in drug development