Sr. Principal Scientist Process

ph3Senior Principal Scientist /h3 pLocation: Schaffhausen, Switzerland. /p h3Overview /h3 pJohnson Johnson Innovative Medicine is recruiting for a Senior Principal Scientist in the Global Process, Biotherapeutic’s Drug Product Development and Delivery organization. The candidate will lead process development and technology transfer of fill/finish manufacturing processes for biotherapeutic products and partner with MSAT, Quality, Regulatory, and other functions to ensure implementation of manufacturing processes that meet regulatory requirements. /p h3Primary Responsibilities /h3 ul liLead late‑stage process development, technology transfer, process validation, and filing activities between manufacturing sites, providing scientific support and project management. /li liAuthor technical transfer documents, including protocols, reports, criticality analysis, and regulatory submissions. /li liSupport local or external manufacturers troubleshooting parenteral products requiring scientific expertise. /li liServe as subject matter expert for scientific aspects of fill/finish manufacturing during internal and external audits. /li liPartner with cross‑functional groups to ensure processes comply with JJ IM platforms, CMC dossiers, and cGMP regulations. /li liProvide feedback to development teams on technical performance and consistency with JJ IM process development approach. /li liParticipate in networking to ensure seamless transfer of drug product manufacturing processes from lab to pilot to commercial scale. /li liContribute to defining scientific strategies for new product introductions for fill‑finish processes to external or internal manufacturers. /li liWork independently, driving impact and innovation. /li /ul h3Qualifications /h3 ul liTechnical expertise in current and future manufacturing principles and processes, preferably in large molecule fill and finish. /li liDemonstrated competency and experience in biologics drug product development within the biopharmaceutical industry. /li liEvidence of advancing scientific/technical knowledge and incorporating advancements aligned with business needs, regulations, and compliance. /li liExperience in biopharmaceutical process design, technology transfer, and drug product fill/finish operations. /li liFamiliarity with container‑closure systems, including vials, syringes, and related delivery devices. /li liStrong collaboration and influence skills across cross‑functional teams. /li liExcellent oral and written communication skills in German and/or English. /li liMotivated, self‑starter with high autonomy and demonstrated problem‑solving skills. /li /ul h3Degree /h3 pMaster’s degree or PhD in a technical field (Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy, or related field) with at least 10 years of experience, including relevant academic research, in biopharmaceutical development and manufacturing. /p h3Physical Requirements / Working Conditions /h3 pTravel: 10–30% – project dependent. /p h3Required Skills /h3 ul liAnalytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Collaboration, Data Synthesis, Drug Discovery Development, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Scientific Research, Tactical Planning, Technical Credibility. /li /ul /p #J-18808-Ljbffr