Principal Scientist, Potency Assays

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 Process Science & Validation Team. 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!

SUMMARY

Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to be the Scientific Leader for the Potency Assay group. This role supports the development of novel therapeutic antibody programs with a focus on methods to determine the potency of drug product for early through late stage clinical development programs. 
 
The successful candidate must have a strong background and demonstrated leadership in developing cell-based potency assays as well as binding/immunoassays. Responsibilities include a primary role in defining, developing and optimizing new potency assays and then guiding method transfers, qualifications and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a thorough understanding of the regulatory and industry standards that are required for potency methods that will ultimately contribute to our registration packages. This role will interact with Lundbeck Seattle Upstream, Downstream, Formulation, and Quality Control groups as well as research colleagues located in Denmark, so strong interpersonal skills will be beneficial.  

ESSENTIAL FUNCTIONS

• Independently develop strategy for potency assays including justification for design of assay and link to mechanism of action (MOA)
• Develop, optimize and qualify potency methods (including cell-based bioassay and ligand binding potency assays) that are intended for lot release, stability-testing, product characterization, reference standard qualification and comparability evaluation
• Provide scientific leadership and management of junior staff in the Potency Assay group with responsibility for potency methods for all development programs (from early to late phase clinical development)
• Author and review SOPs, development reports, and technical reports
• In partnership with QC, serve as the Subject Matter Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs)
• Collaborate with QC to ensure successful method validation at contract labs/CMOs; support investigations and lead troubleshooting efforts as required
• Collaborate with Lundbeck research to influence potency assay design and cell-line selection
• Prepare and qualify cell banks required for cell-based bioassays; partner with QC to establish and qualify GMP analytical cell banks at contract labs (suitable for use in GMP testing)
• Oversee routine analytical testing and coordinate study support across Quality Control (QC) and Process Development (PD) groups 
• Oversee routine maintenance of laboratory equipment and the critical reagent program for potency methods
• Develop and maintain processes for tracking assay performance
• Identify and implement new technologies and innovative approaches to measure the potency of our pipeline molecules
• Represent the Potency Assay function on cross-functional project teams 
• Assist in the preparation of CMC regulatory submissions including authoring and/or review

 
REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Ph.D. or M.S. in cell biology, molecular biology, biochemistry or related field with 8+ years of relevant experience (for Ph. D) or 12+ years relevant experience (for M.S) in biologics
• Strong technical skills including demonstrated experience in leading the development and optimization of potency assays (including cell-based bioassays) with solid understanding of requirements for transfer and validation of the method for use by QC
• In depth knowledge of cGMP regulations, compendial requirements and regulatory requirements for potency assays
• Ability to translate the mechanism of action into a cell-based assay 
• Demonstrated ability to effectively and independently manage laboratory work and data, including proficiency in data and statistical analyses
• Expe