Lead Scientist, Potency Testing

2 weeks ago

Bothell, Washington, United States Healthcare Businesswomen's Association Full time

Overview

Are you passionate about contributing to meaningful scientific advancements? The Healthcare Businesswomen's Association is seeking a dedicated and experienced professional to take on the role of Lead Scientist for the Potency Testing division. This position plays a crucial role in the development of innovative therapeutic antibody programs, focusing on methodologies to assess the potency of drug products throughout various stages of clinical development.

Key Responsibilities

  • Independently formulate strategies for potency assays, ensuring alignment with the mechanism of action (MOA).
  • Design, refine, and validate potency methodologies, including cell-based bioassays and ligand binding assays, for applications such as lot release and stability testing.
  • Provide scientific guidance and mentorship to junior team members within the Potency Testing division, overseeing potency methodologies across all development phases.
  • Draft and evaluate standard operating procedures (SOPs), development reports, and technical documentation.
  • Collaborate with Quality Control (QC) to facilitate the transfer of analytical methods to contract laboratories and manufacturing organizations.
  • Work closely with QC to ensure successful validation of methods at external laboratories; support investigations and lead troubleshooting efforts as necessary.
  • Engage with research teams to influence the design of potency assays and the selection of cell lines.
  • Prepare and qualify cell banks essential for bioassays, partnering with QC to establish GMP-compliant analytical cell banks.
  • Oversee routine analytical testing and coordinate support across QC and Process Development teams.
  • Manage laboratory equipment maintenance and the critical reagent program for potency methodologies.
  • Develop and maintain systems for monitoring assay performance.
  • Identify and implement innovative technologies and approaches to enhance potency measurement for pipeline molecules.
  • Represent the Potency Testing function in cross-functional project teams.
  • Assist in the preparation of regulatory submissions, including drafting and reviewing documentation.

Qualifications

The ideal candidate will possess a Ph.D. or M.S. in cell biology, molecular biology, biochemistry, or a related discipline, with significant experience in biologics development. A strong technical background in the development and optimization of potency assays, along with a comprehensive understanding of regulatory requirements, is essential.

Preferred Skills

  • Experience in team management and development.
  • Familiarity with regulatory submission processes, including drafting and responding to inquiries.

Travel Requirements

Willingness to travel domestically and internationally as needed.

Why Choose Us

The Healthcare Businesswomen's Association is committed to fostering a diverse and inclusive workplace. We offer a comprehensive benefits package designed to support the well-being of our employees and their families.

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