Job Title: Senior Director, Global R&D Scale Up and Pilot PlantReporting to: VP and Head of Global Process DevelopmentCFL: 10M/P: MNumber of direct / indirect reports: 3-4 / 20-30Location: KAN / MRB / BRNPosition Description SummaryThe Senior Director, Global R&D Scale Up and Pilot Plant will create strategy and be a global change leader of global teams responsible for 1) GMP manufacturing of clinical trial material for the R&D portfolio as well as execution of pilot scale processes to verify process scalability and provide representative intermediate materials for LCM and NPD process development activities 2) Provide process scale-up expertise at various scales from bench scale to pilot scale, 3) develop automation strategies and ensure that best and aligned automation practices are implemented across the Pilot plant and Global PD teams and 4) across the Enterprise PP Network, establish the blueprint for future manufacturing concepts design, and influence how processes will be run in the future. In addition, he/she is integral to the development of global strategies, new manufacturing technologies, and initiatives for the Global Process Development organization as it relates to the global R&D project portfolio.Main Responsibilities & AccountabilitiesResponsible for establishing a long-term strategy for Pilot plant and Scale-up support across R&D and the broader EnterpriseOversees all areas of development of short to medium PPD Pilot Plant and Scale-up strategies includingDevelopment of a holistic PP and Scale-up strategy to ensure that pre-clinical, clinical, and development supplies are produced at the appropriate quality to meet RACE, PACE, or TRACE timeline expectationsOperates with an Enterprise mindset and considers and promotes novel and innovate solutions outside the PPD PP networkCommunicates rapidly and with candor to brief execs on milestone achievements or unexpected key activities. Able to intervene and respond with urgency.Responsible for the technical execution of pilot scale runs and intermediate materials productionLeads global teams accountable for the execution of GLP Tox/GMP clinical trial materials for R&D programs. Manages the network so that high quality, complaint material is available for our programs and patients.Leads global teams accountable for the execution of pilot scale runs to designed to address the scalability of bench scale processesLeads global teams accountable for the execution of pilot scale runs providing sufficient and timely representative intermediate materials for process development activitiesLeads the global the scale-up and automation team to support PD across all relevant sites and ensures the availability of facilities and equipment.Establishes an Operational Culture of Excellence with regards to Safety, Quality and First Time Right execution and operates as a role model to deliver Quality expectations while establishing psychological safety across PP operationsDevelops scale-up and automation strategies and implements best practices across the global PD labsLeads with an Enterprise mindset through direct or indirect collaborations across the Enterprise PP networkDrive future manufacturing concepts through the pilot plant network, be the blueprint for future commercial manufacturing. Utilize & implement best practices across the industry via networking with industry consortiums, universities, and industry-wide conferences.Lead the evaluation of new technologies, concepts, and strategies to bring improved efficiencies to pilot scale operationsNetwork and collaborate across the Enterprise PP and scale-up network , and with partner functions such as process engineering and network strategy to develop short through long term strategies and solutionsCreative/agile and influential in marshalling staffing resources including operations resources when neededTalent/Management Responsibilities & AccountabilitiesManages the global delivery of a complex and interconnected global portfolio of tasks to ensure aggressive R&D timelines are metOversight of the global function with a leadership team comprised of Director and AD levelsInitially accountable for a staff of 20-30 staff members located in Europe and the US with potential future global responsibilitiesAccountable for the development of leadership and technical talent and succession planning within the respective remit as well as the broader R&D organization.Qualifications & Experience RequirementsRequires a BS or MS in Biochemistry, Chemical Engineering, Life Sciences or other closely related discipline; PhD or equivalent preferred.7-10 or more years Industry and managerial experience in pharmaceutical and biological operations, including biological/protein process dev., Pilot plant and scale-up experience highlyDemonstrated leadership, proven change leadership, and ability to influence with an enterprise mindsetRequires advanced business knowledge, general management, and leadership with the capability to lead multiple global teams.Sound scientific understanding of process and product drug development; experience in GMP operations is highly favorableExperience in medium to long term strategy development and managing global functions is desiredWorking knowledge of relevant international guidance documents related process development, tech transfer, comparability, and QbD principlesTravel up to 30% may be required.Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring (https://www.cslbehring.com/our-company) .We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.Do work that matters at CSL Behring!R-244640CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
