Lead Scientist, Potency Evaluation

1 week ago

Bothell, Washington, United States Lundbeck Full time

Are you ready to be part of a team where your contributions matter, the challenges are intricate, and you can witness the impact 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 pivotal role in the commercial launch of Lundbeck's inaugural biologic product and is advancing a promising pipeline of biologics in collaboration with our Process Science & Validation Team.

POSITION OVERVIEW

Lundbeck Biopharmaceuticals is on the lookout for a driven and seasoned professional to take on the role of Scientific Leader for the Potency Assay team. This position is integral to 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, alongside binding and immunoassays. Key responsibilities include defining, developing, and refining new potency assays, overseeing method transfers, qualifications, and validations, and serving as a Subject Matter Expert. A comprehensive understanding of regulatory and industry standards for potency methods is essential, as these will contribute to our registration packages. This role requires collaboration with various Lundbeck teams, necessitating strong interpersonal skills.

KEY RESPONSIBILITIES

  • Formulate strategies for potency assays, ensuring alignment with the mechanism of action (MOA).
  • Design, optimize, and validate potency methods, including cell-based bioassays and ligand binding assays, for lot release, stability testing, product characterization, and reference standard qualification.
  • Provide scientific guidance and manage junior team members within the Potency Assay group, overseeing potency methods across 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 in transferring analytical methods to GMP contract laboratories.
  • Work alongside QC to ensure successful method validation at contract laboratories; lead troubleshooting efforts as necessary.
  • Partner with Lundbeck research to influence assay design and cell-line selection.
  • Prepare and qualify cell banks for bioassays, collaborating with QC to establish GMP analytical cell banks.
  • Supervise routine analytical testing and coordinate study support across QC and Process Development teams.
  • Manage laboratory equipment maintenance and the critical reagent program for potency methods.
  • Develop processes for monitoring assay performance.
  • Identify and implement innovative technologies to enhance potency measurement 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 discipline with extensive relevant experience.
  • Strong technical expertise in developing and optimizing potency assays, particularly cell-based bioassays.
  • In-depth knowledge of cGMP regulations and regulatory requirements for potency assays.
  • Ability to translate mechanisms of action into effective cell-based assays.
  • Proven ability to manage laboratory work and data independently, with proficiency in data 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 and attention to detail.
  • Ability to work collaboratively in a multidisciplinary team environment.
  • Experience managing direct reports.

PREFERRED QUALIFICATIONS

  • Experience in team management and development.
  • Background in supporting regulatory submissions and responding to inquiries.

TRAVEL REQUIREMENTS

  • Willingness to travel domestically and/or internationally as needed.

Lundbeck offers a comprehensive benefits package designed to support employees in maintaining their health and well-being. We are committed to fostering an inclusive workplace and providing reasonable accommodations for individuals with disabilities throughout the application process.

Lundbeck is proud to be an equal opportunity employer, committed to diversity and inclusion in the workplace.

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