Director / Senior Director, Analytical Development & Quality Control (AD/QC)

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Company Summary  

Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.

 

General Responsibilities:

The successful candidate will help to advance Leap’s clinical pipeline by leading all Analytical Development and Quality Control (AD/QC) activities at external testing labs, including assay development and validation, routine release and stability testing, and characterization.

This candidate will serve as the subject matter expert (SME) representing AD/QC at internal and external meetings.

They will build and mentor the internal AD/QC team, while collaborating with functional areas including process development, manufacturing, and QA.

 

Specific Responsibilities Include:

  • Design study protocols, review and trend stability studies and lot release data for drug substance, drug product, and reference standards.
  • Directly manage a team of scientists from a variety of levels of experience by providing guidance, support, and mentorship of both a scientific and career-development nature.
  • Provide analytical support to upstream and downstream process development and manufacturing teams; specifically in the area of quality assessment of intermediates and impurity identification, characterization, and clearance.
  • Provide AD/QC technical input into investigations, deviations, out-of-specification, change controls, and CAPAs at contract sites, including general assay troubleshooting support.
  • Author relevant CMC sections for drug substance and drug product regulatory filings, both US and ROW.
  • Review and approve assay qualification and validation protocols and reports.
  • Direct activities pertaining to novel analytical method development.
  • Guide the comparability and extended characterization strategies for product development.
  • Guide the development of product specifications.
  • Aid in the preparation of appropriate Standard Operating Procedures.
  • Maintain the budget for this functional area.
  • Manage the testing timelines in support of clinical programs.

 

 Education / Experience / Skills:

  • Advanced degree in a scientific field. (PhD preferred)
  • Minimum of 10+ years of progressive experience in analytical development and quality functions in pharmaceutical/biotech industry with extensive GMP biologics experience.
  • Analytical experience working with biologics required, preferably with both monoclonal and bispecific antibodies.
  • Previous experience in QC management is preferred, as well as strong skills providing technical leadership to outsourced contract organizations, supporting both testing and manufacturing. This includes directing method transfers and execution of validation studies.
  • Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines.
  • Demonstrated experience developing and maintaining a budget forecast.
  • Proven track record of thinking critically and creatively and being able to work independently, determine appropriate resources for resolution of problems, and having strong organizational and planning skills.
  • Hands-on leader, able to provide solution-minded approaches and flexibility to emerging challenges.
  • Demonstrated track record leading and managing high performing teams by building productive relationships with direct reports.
  • Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop strong working relationships with cross functional personnel at all levels.
  • Previous experience with Cell Based assays is strongly preferred.

 

Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.