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!
Responsible for building and the ongoing leadership of a lean and effective Drug Product Technology function at Lundbeck that will play a key role in developing technologies for large scale drug product manufacture of antibody and antibody-based therapeutics. In collaboration with team members in Analytical, Quality and Drug Substance groups, the Director, Drug Product Technology will ensure that our drug product production process is robust, scalable, well characterized and economical.
- Guide the development, scale-up and production of drug product presentations for use by physicians and patients.
- Collaborate with Lundbeck’s network of contract manufacturers on technology transfer, process improvements and troubleshooting equipment and operational issues.
- Strengthen the technical capacity for drug product process development and improve in-house expertise and laboratory capacity
- Facilitate growth of the department, such as incorporate new technologies and establish best practices
- Initiate and support technical transfer and manufacturing activities at fill finish CMOs. Establish and maintain excellent working relationship with internal and external partners to deliver successful manufacturing processes
- Be responsible for reviewing and authoring of drug product sections of regulatory submissions. Serve as SME and provide strategy guidance for key regulatory interactions
- Support budgeting
- Recruit, motivate and develop staff, encourage professional growth and operational excellence
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
- Accredited Master’s degree
- 10+ years of biological or/and small molecule pharmaceutical development experience
- Proven success in process scale-up and manufacturing support, familiarity with current Good Manufacturing Practices and US/EU regulations, cGCP (FDA, ICH, and ISO) requirements and regulatory guidelines as well as advanced practical and theoretical knowledge of common industry drug product process unit operations
- Capable of highly collaborative approach and proven ability to work in a fast paced, team-oriented environment
- Proven success in demonstrating flexibility, independence, and ability to prioritize and manage multiple tasks simultaneously in a changing environment.
- Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs
PREFERRED EDUCATION, EXPERIENCE AND SKILLS
- Ph.D. in Chemical or Biochemical Engineering or in comparable field
- 5+ years of supervisory or leadership experience
- Experience working with CRO and CMO
- Experience in working with products for intravenous and subcutaneous routes of administration
- Working knowledge of aseptic processing and experience in technology for parenteral drug product manufacturing
- Working knowledge of Quality by Design and Design of Experiment principles
- Understanding of critical quality attributes and analytical characterization of biopharmaceutical drug product
- Strong analytical skills, problem-solving ability, and presentation skills required.
- Domestic travel up to 10%. International travel may be required.