Principal Scientist, Therapeutic Assays
1 week ago
Are you interested in becoming part of a team where the mission is impactful, the challenges are intricate, and you can witness the outcomes of your efforts? Lundbeck Seattle BioPharmaceuticals (Lu-SBP) is at the forefront of Process Development for Biologics within the global Lundbeck CMC organization. Since joining Lundbeck, Lu-SBP has played a crucial role in the commercial launch of Lundbeck's first biologic product and the progression of a promising biologics pipeline in partnership with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team is dedicated to advancing new product candidates from cell line development to the commercial validation of Drug Substance and Drug Product manufacturing processes. Join us in our commitment to innovation aimed at addressing significant medical needs related to brain diseases.
POSITION OVERVIEW
Lundbeck Biopharmaceuticals is on the lookout for a highly driven and seasoned professional to take on the role of Scientific Leader for the Potency Assay team. This position is pivotal in the development of innovative therapeutic antibody programs, focusing on methodologies to assess the potency of drug products throughout various stages of clinical development.
The ideal candidate will possess a robust background and proven leadership in the creation of cell-based potency assays as well as binding/immunoassays. Key responsibilities include defining, developing, and optimizing new potency assays, overseeing method transfers, qualifications, and validations, and ultimately serving as a Subject Matter Expert. A comprehensive understanding of regulatory and industry standards necessary for potency methods is essential, as these will contribute to our registration packages. This role will require collaboration with various Lundbeck departments and research teams, making strong interpersonal skills vital.
KEY RESPONSIBILITIES
Formulate strategies for potency assays, including rationale for assay design and its connection to the mechanism of action (MOA). Develop, refine, and validate potency methods (including cell-based bioassays and ligand binding assays) for lot release, stability testing, product characterization, reference standard qualification, and comparability assessments. Provide scientific guidance and mentorship to junior team members in the Potency Assay group, overseeing potency methods for all development phases. Draft and review Standard Operating Procedures (SOPs), development reports, and technical documentation. Collaborate with Quality Control (QC) as the Subject Matter Expert (SME) in transferring analytical methods to GMP contract laboratories and manufacturing organizations. Work alongside QC to ensure successful method validation at contract facilities; lead troubleshooting efforts as necessary. Partner with Lundbeck research to influence the design of potency assays and the selection of cell lines. Prepare and qualify cell banks for cell-based bioassays; collaborate with QC to establish and qualify GMP analytical cell banks at contract labs. Supervise routine analytical testing and coordinate study support across QC and Process Development teams. Manage routine maintenance of laboratory equipment and the critical reagent program for potency methods. Develop and maintain processes for monitoring assay performance. Identify and implement new technologies and innovative methods for measuring the potency of pipeline molecules. Represent the Potency Assay function in cross-functional project teams. Assist in preparing CMC regulatory submissions, including authoring and reviewing documentation.REQUIRED QUALIFICATIONS
Ph.D. or M.S. in cell biology, molecular biology, biochemistry, or a related field with extensive relevant experience. Strong technical expertise in leading the development and optimization of potency assays, with a solid grasp of transfer and validation requirements for QC. In-depth knowledge of cGMP regulations, compendial standards, and regulatory requirements for potency assays. Ability to translate mechanisms of action into cell-based assays. Proven capability to manage laboratory work and data independently, including proficiency in data and statistical analysis. Familiarity with statistical methods for evaluating potency data. Proficient in common software and data analysis tools. Excellent communication, technical, and organizational skills. Strong critical thinking, troubleshooting abilities, and attention to detail. Strong interpersonal skills and the ability to collaborate in a multidisciplinary team environment. Experience managing direct reports.PREFERRED QUALIFICATIONS
Experience in team management and development. Experience in supporting regulatory submissions, including authoring and responding to inquiries.TRAVEL REQUIREMENTS
Willingness to travel up to 10% domestically and/or internationally.The salary range for this position is competitive and may vary based on factors such as qualifications and experience. Additional benefits include flexible paid time off, comprehensive health benefits, and a 401k plan with company matching.
Why Choose Lundbeck
Lundbeck is dedicated to providing a comprehensive benefits package to support employees in their health, family, and daily lives. We are committed to fostering an inclusive workplace and providing reasonable accommodations for individuals with disabilities during the application process.
Lundbeck is proud to be an equal opportunity employer, committed to diversity and inclusion in the workplace.
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