Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Late-Stage Development and Production groups. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!
POSITION IS IDEALLY BASED IN BOTHELL, WASHINGTON BUT CAN BE BASED IN VALBY, COPENHAGEN
The Vice President, Global CMC Development Quality Assurance will be based in Seattle (Bothell), WA and is responsible for the ongoing development of the CMC development QA functions in both Seattle (Bothell), WA & Copenhagen. The role provides strategic and technical leadership of quality activities and deliverables in support of our pipeline consisting of a mix of biologics compounds and synthetic molecules.
The CMC business area has employees equally divided between the US and DK and is comprised of 3 divisions: CMC Development Quality (CMC Dev’t QA), Chemical & Pharmaceutical Development (C&PD) & CMC Biologics (CMCB). CMC is part of the Product Development and Supply (PDS) organization. CMC Dev’t QA consists of three departments across Seattle (Bothell), WA and in Copenhagen employing approximately 20 colleagues. This role reports to the SVP, CMC who is based in Copenhagen.
- Serve as an active member of the global CMC Leadership Team responsible for development and setting of Quality and Quality-related strategy and goals
- Lead the global quality function and define and implement the appropriate organizational structure to create a global, agile CMC Development Quality organization
- Collaborate with the leadership Corporate Product Quality (CPQ) and continue to grow the interaction between the CMC development QA and the QA functions for commercial products (CPQ)
- Implement the CMC strategy in the quality function via objectives and plans to ensure quality oversight, timely resolution of issues, and early intervention to assure appropriate compliance
- Lead the establishment of a Medical Device Quality Management System, a newly added discipline in the Lundbeck CMC organization
- Develop and drive Quality cross-site initiatives
- Coach, lead and develop direct reports to build a highly capable team of senior quality professionals
- Grow our on-going relationships with CMOs for our pipeline projects
- Execute quality oversight is in line with applicable regulations and guidance as well as industry best practices, including leading the CMC Quality Management Reviews and reporting these to R&D Quality Council as well as Product Development & Supply management
- Participate in CMC project governance boards and provide strategic quality guidance for CMC focus teams
- Ensure that the CMC function maintains compliance for personnel qualification, training, procedures and processes and drive continuous improvement of the quality system
- Be part of an ambitious culture of risk-based thinking, curiosity, and with an eye towards flexibility of processes to meet the evolving needs of the business
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Bachelor’s Degree
- 10+ years of experience managing quality systems covering GxP quality assurance
- Extensive background, experience and knowledge in the biologic drug development process, drug device combinations or small molecule drug development.
- Established expertise in GxP systems. Extensive knowledge of global regulations and standards and experience in managing regulatory inspections and their application through the stages of product development to commercial readiness.
- Previous management experience in various quality aspects of global biologics, pharmaceutical or medical device manufacturing
- Strong people leadership skills and a great ability to attract, retain, and engage employees
- Manages ambiguity and thrives in a dynamic and changing environment
PREFERRED EDUCATION, EXPERIENCE and SKILLS:
- 10+ years of experience in CMC development quality leadership covering GxP quality assurance
- Extensive background, experience and knowledge of the biologic drug development process.
- Additional experience in drug device combinations as well as small molecule drug development is a strong plus
- Masters or other advanced degree in a scientific background e.g. Master of Science, or equivalent
- Experience with small molecule drug and device development
- Global leadership team experience
- Experience leading teams through change
- Collaboration with CMOs
- Willingness/Ability to travel up to 20% domestically and internationally as needed.