Ph3Job Function /h3 pDiscovery Pre-Clinical/Clinical Development /p h3Job Sub Function /h3 pBiotherapeutics RD /p h3Job Category /h3 pPeople Leader /p h3Location /h3 pSchaffhausen, Switzerland /p h3Job Description /h3 pDirector – Biotherapeutics RD (Proteins) leading a critical function within the Proteins Development organization, driving scientific excellence, innovation, and operational performance across drug product analytical development and combination product support. /p h3Responsibilities /h3 ul liManaging an Analytical Development department with focus on Drug Product assay development/qualification/validation/transfer, analytical support for Combination Products, investigations, and complaints, as well as Pilot Plant support. /li liEnsure best scientific, technical EHS and GMP standards. /li liEnsure efficient and successful development of new products in a timely manner while maintaining high standards of quality. /li liProvide strategic and scientific direction in analytical development areas, in particular serve as the large molecule analytical development expert on drug product, combination product testing, test method development and validation and establishment of specifications. /li liSupport the preparation of technical reports, regulatory submissions, participate in their review, and contribute to development of strategies to comply with international regulatory standards. /li liParticipate in industry and Regulatory forums to shape Regulator strategies. /li liProvide scientific guidance on complex drug product manufacturing investigations with focus on analytical aspects. /li liLead discussions to identify new scientific/technical opportunities for the large molecule product platform, and negotiate/ influence acceptance of new opportunities and concepts through scientific leadership. /li liSupport a learning environment and foster a culture of scientific excellence through training, influence and leading by example. /li liAct as a senior internal expert with a direct impact on DPDS TDS Proteins Development Value Stream business objectives. /li liMentor team members and foster a culture of excellence and inclusion. /li /ul h3Required Qualifications /h3 ul liPhD in Analytical Chemistry, Biochemistry, or related scientific discipline. /li li10+ years of experience in biopharmaceutical analytical development, with strong focus on drug product and devices. /li liDemonstrated expertise in: Method development, validation, and lifecycle management; Combination product analytical requirements; Regulatory submissions and interactions; Proven leadership experience managing complex teams and cross-functional stakeholders; Strong knowledge of GMP, EHS, and regulatory expectations. /li /ul h3Preferred Qualifications /h3 ul liExperience with automation, digitalization, and advanced analytical platforms. /li liExperience supporting novel therapeutic modalities. /li liTrack record influencing regulatory or industry standards. /li /ul h3Required Skills /h3 ul liStrategic Thinking. /li liScientific Leadership. /li liStakeholder Management. /li liAnalytical Development Expertise (CMC). /li liRegulatory Knowledge. /li liDecision Making Problem Solving. /li liDeveloping Others Inclusive Leadership. /li liOperational Excellence. /li /ul h3Key Working Relationships /h3 pInternal: TA, DPDS, API, DPDD, CSC, CMC Teams, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing QC. /p pExternal: Health Authorities, Industry Forums, Contract Organizations (CROs/CDMOs), Scientific Networks. /p h3Additional Skills /h3 pRequired Skills: Analytical Reasoning, Biochemistry, Business Savvy, Chemistry, Manufacturing, Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Compliance Management, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Operational Excellence, Pharmacovigilance, Process Improvements, Productivity Planning, Product Strategies, Program Management, Scientific Research, Stakeholder Management. /p pPreferred Skills: Analytical Reasoning, Biochemistry, Business Savvy, Chemistry, Manufacturing, Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Compliance Management, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Operational Excellence, Pharmacovigilance, Process Improvements, Productivity Planning, Product Strategies, Program Management, Scientific Research, Stakeholder Management. /p /p #J-18808-Ljbffr