Job Title: Senior Director, Global R&D Scale Up and Pilot Plant
Reporting to: VP and Head of Global Process Development
CFL: 10
M/P: M
Number of direct / indirect reports: 3-4 / 20-30
Location: KAN / MRB / BRN
Position Description Summary
The 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 & Accountabilities
Responsible for establishing a long-term strategy for Pilot plant and Scale-up support across R&D and the broader Enterprise
Oversees all areas of development of short to medium PPD Pilot Plant and Scale-up strategies including
•Development 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 expectations
•Operates with an Enterprise mindset and considers and promotes novel and innovate solutions outside the PPD PP network
•Communicates 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 production
•Leads 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 processes
•Leads global teams accountable for the execution of pilot scale runs providing sufficient and timely representative intermediate materials for process development activities
•Leads 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 operations
Develops scale-up and automation strategies and implements best practices across the global PD labs
Leads with an Enterprise mindset through direct or indirect collaborations across the Enterprise PP network
•Drive 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 operations
•Network 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 solutions
•Creative/agile and influential in marshalling staffing resources including operations resources when needed
Talent/Management Responsibilities & Accountabilities
•Manages the global delivery of a complex and interconnected global portfolio of tasks to ensure aggressive R&D timelines are met
•Oversight of the global function with a leadership team comprised of Director and AD levels
•Initially accountable for a staff of ~20-30 staff members located in Europe and the US with potential future global responsibilities
•Accountable 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 Requirements
•Requires 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 highly
•Demonstrated leadership, proven change leadership, and ability to influence with an enterprise mindset
•Requires 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 favorable
•Experience in medium to long term strategy development and managing global functions is desired
•Working knowledge of relevant international guidance documents related process development, tech transfer, comparability, and QbD principles
•Travel up to 30% may be required.
Our Benefits
CSL 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 to see what’s available to you as a CSL employee.
About CSL Behring
CSL 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.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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