Associate Director, Project Management
Lonza, Inc. Walkersville, MD
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary Associate Director, Project Management Location: Walkersville, MD Job Description Summary The Operations Project Manager will lead the project management integration of the operations team’s activities into the overall project schedule in support of our Bioscience strategy implementation at our Walkersville, MD facility. This facility manufactures medical devices for Bioscience media/solutions and endotoxin test kit products. Key responsibility is overall operations project management integration of the Operational Readiness Work stream across Quality, Manufacturing, Engineering, MSAT, OE, Supply Chain, HR, SHE, IT and Finance to ensure all operational systems and processes are in place and integrated with the project delivery schedule. Job Description Main Responsibilities: Lead the site operations readiness work stream interfacing with the project to ensure the facility will operate as per the user requirements and the delivery of key project milestones Ensure robust operational readiness plans (ORP) are developed by each function. Ensure they are aligned and integrated across the site and with the project and provide regular visibility on progress. ORP to include as applicable (to be fully defined by this role): Documentation strategy including generating and updating SOP`s FAT/SAT strategy and detailed plans Conduct FMEA’s and HazOps as needed Assuring that calibration and testing plans are carried out to plan Production and staff planning to feed into Opex budgeting process Quality Agreement or Service Level Agreement Equipment characterization plan and facility capability report (as needed) Wet test run plan and summary report (as needed) OE components for operating model (e.g. standard work, process map/value stream maps) Sourcing of critical raw materials, spare & small parts Commissioning protocols and reports Facility validation master plan Cleaning characterization studies (as needed) Cleaning validation/verification plan Computer/Automation validation master plan Equipment PQ protocols and reports Training for staff including process and safety overview Tech Transfer and Regulatory strategies are in place (as needed) Operational and Building Occupancy readiness checklists Establish and development work streams for each critical aspects of the ORP plan with key leaders in place to deliver on those work streams Support the HR People work stream in the creation of a robust learning and development plan. (The plan as delivered by the HR People Work stream) In partnership with the Program team, create and sustain a culture of excellence in safety, quality and continuous improvement. Responsible for ensuring compliance with legal, EHS and all Lonza policies and procedures, which are applicable to the site. Responsible for ensuring compliance to all requirements of current Good Manufacturing Practice Perform other duties as assigned. Minimum Required Qualifications: Education: Bachelor of Science or Engineering degree or equivalent Work experience: Highly experienced individual within the Pharmaceutical or Biologic Manufacturing / Quality area. Medical device manufacturing experience, project management as well as start-up experience Skills: Enterprise mindset to ensure the right prioritization for the delivery of the ORP Strong project management skills to support project delivery and operational readiness Strong stakeholder management skills to manage both internal and external stakeholders that support the Program The ability to lead a complex set of projects in terms of operational readiness management. Excellent trouble shooting and problem solving skills. Ability to challenge the status quo with a continuous improvement mindset Proven ability to using a wide variety of lean tools and building capability in teams you have led that becomes the standard way work gets completed Change agent who will support the organization with good change management tools and techniques Effective communicator Complexity and Problem Solving Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.