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.
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders.
Ensure drug product processes are robust, scalable, well-characterized, and economical for pipeline molecules. The role will interact with internal product development groups and with Lundbeck’s external CMOs/contract labs. Primary responsibilities involve leading programs by supporting clinical and commercial manufacturing, designing and overseeing laboratory experiments supporting process development, technology transfer, deviation closure, data analysis and trending utilizing statistics, and authoring complex reports supporting process validation for drug product.
- Lead programs involving a wide variety of process development and manufacturing activities including:
- Author GMP protocols and in-process test plans to meet development and commercialization timelines
- Generate and implement design of experiments with subsequent statistical analysis of data
- Author regulatory sections for regulatory filings
- Perform on-site troubleshooting during process scale-up (international travel required)
- Interpret analytical results, present findings, and write complex technical reports used as primary references for regulatory filings
- Represent process development and manufacturing on one or more internal project teams and also on CMO/external project teams to ensure successful process transfer
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Ph.D. with 5 years of biopharma industry experience, accredited Master’s degree with 10 years of biopharma industry experience, accredited Bachelor’s degree with 12 years of biopharma industry experience a OR a combination of education and experience or a combination of education and biopharma experience totaling 15+ years
- In-depth understanding of unit operations used for formulation and aseptic fill-finish/drug product manufacturing of liquid formulations of monoclonal antibodies.
- Demonstrated experience including developing acceptance criteria for technology transfer and validation
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Ph.D. in a relevant scientific discipline (such as engineering, physical / analytical chemistry
- Experience with development of combination products (PFS, AI etc.)
- Experience with high concentration pre-filled syringe configurations
- Willingness/Ability to travel up to 10% domestically and internationally.