Associate Director of Upstream Process (USP) Operations (m/f/d)

ppOur Company’s Schachen site serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them. Schachen Biotech is a premier, state‑of‑the‑art facility that integrates advanced technologies into the early‑stage clinical pipeline, refining them for future commercial launch. /ppThe site supports biologics drug substance manufacturing for early‑phase clinical supply and serves as a hub for technology innovation and strategic advancement. /ph3Job Overview /h3pThe Associate Director of Upstream Process (USP) Operations plays a pivotal role in leading both day‑to‑day USP manufacturing execution (vial thaw, seed train, and bioreactor operations through harvest) and strategic support functions with focus on cultivating people leadership and operational excellence. The role ensures the facility operates with agility and readiness to support a multiproduct pipeline for early‑phase clinical supply. /ph3Responsibilities /h3ulliOversee USP shop‑floor operations, production planning, and operational readiness for new product introductions (NPIs). /liliDrive digitization, automation, and continuous improvement. /liliManage a team of process specialists and operators, fostering a culture of safety, compliance, and performance excellence. /liliEnsure reliable, efficient, and cGMP‑compliant execution of USP production campaigns from vial thaw to harvest. /liliOversee process implementation activities for new and existing products, batch record review, deviation management, campaign reporting, and calibration activities. /liliLead operational simplification and digital solutions, including robotic process automation (RPA). /liliCollaborate cross‑functionally to ensure tech transfer readiness and contribute to Quality Risk Assessments (QRAs). /liliChampion digitization and automation to enhance efficiency, agility, and readiness for clinical campaigns. /liliDrive harmonization of standards and sharing of best practices across the network. /li /ulh3Leadership Culture /h3pLead a diverse team of process specialists and operators within USP operations, fostering a culture of empowerment, accountability, collaboration, and trust. /ppBuild team capabilities through hiring, mentoring, coaching, and performance development, fostering a high‑performance culture rooted in operational excellence. /ppPromote our Company’s Ways of Working by embedding a "Safety First, Quality Always" mindset. /ppDrive continuous improvement and innovation, encouraging agility and adaptability in a multiproduct environment. /ppRepresent the USP Operations function in cross‑functional forums and contribute to site‑wide strategic initiatives. /ph3Operational Management /h3pOversee day‑to‑day manufacturing process execution and support operations, ensuring readiness for clinical campaigns and alignment with GMP standards. /ppLead production planning, resource allocation, and coordination of USP shop floor activities in line with New Product Introduction (NPI) schedules. /ppSupport process implementation for NPIs, including integration of new materials, equipment, and procedures into routine operations. /ppEnsure personnel are appropriately trained and qualified for assigned tasks, maintaining operational readiness and compliance. /ppDrive operational simplification by eliminating non‑value‑added activities and reducing effort and cost through digital solutions. /ppCollaborate cross‑functionally to ensure tech transfer readiness and contribute to Quality Risk Assessments (QRAs). Focus on USP process robustness and scalability. /ph3Quality Compliance /h3pEnsure deployment of Quality Management Systems (QMS). /ppAct as business approver for complex and high‑impact GMP documentation, including validation protocols, change controls, and deviation records. /ppSupport the resolution of complex deviations and CAPAs in collaboration with Quality and Regulatory Affairs. /ppFacilitate Quality Risk Assessments (QRAs) and support internal and external audits. /ph3Required Qualifications /h3ulliBachelor’s or Master’s degree in biology, Chemical Engineering, or related discipline. /liliMinimum 6 years of experience in GMP‑regulated biologics manufacturing, including strong expertise in upstream processing (cell culture, seed train expansion, and bioreactor operations), tech transfer, and single‑use systems. /liliProven leadership experience in manufacturing operations and technical implementation. /liliExcellent oral and written communication skills in English (C1) and German (B2). /li /ulh3Preferred Experience and Skills /h3ulliFamiliarity with multiproduct manufacturing strategies and campaign planning. /liliKnowledge of digital manufacturing platforms (e.g. DeltaV, MES). /liliQualification and Training in LEAN management, or operational excellence methodologies. /li /ulh3Required Skills /h3ulliComputerized Maintenance Management Systems (CMMS). /liliCross‑Cultural Awareness. /liliGMP Environments. /liliMaintenance Supervision. /liliManufacturing Quality Control. /liliPeople Leadership. /liliPharmaceutical Development. /liliProcess Engineering. /liliProcess Improvements. /liliRegulatory Compliance. /liliRegulatory Inspections. /liliSingle‑Use Systems (SUS). /liliSterile Manufacturing. /liliStrategic Thinking. /liliTeam Leadership. /li /ulh3Preferred Skills /h3ulliFamiliarity with multiproduct manufacturing strategies and campaign planning. /liliKnowledge of digital manufacturing platforms (e.g. DeltaV, MES). /liliQualification and Training in LEAN management, or operational excellence methodologies. /li /ul /p #J-18808-Ljbffr