image description

Senior Manager/Associate Director, Analytical Development and Quality Control

Share to LinkedIn Apply Now Apply Now

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 in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap has a strong financial position and in September 2021 closed a public offering with gross proceeds to Leap of approximately $104 million.  Leap is based in Cambridge, MA.  For more information about Leap Therapeutics, visit http://www.leaptx.com

Leap Therapeutics is seeking a motivated individual with substantial biologics analytical development and quality control experience to be part of a growing oncology company.

Work within a highly collaborative team environment to assist in developing and implementing operational plans to meet project timelines and the company’s business objectives.

 

Overview:

The successful candidate will help manage QC activities at external testing labs, including assay development of new analytical methods as well as coordinating and analyzing cGMP release and stability data.  Experience working with and developing “wet bench” methods such as cell-based potency assays and ELISAs is preferable.  They will provide analytical support to drive upstream and downstream manufacturing process development while collaborating with various corporate functions including quality assurance, regulatory, and clinical.

 

Responsibilities:

  • Lead development efforts for new methods, with a particular focus on ELISA and cell-based methodologies
  • Design study protocols, review and trend stability studies and lot release data for drug substance and drug product
  • 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 QC technical input into investigations, deviations, out-of-specification/out-of trend, change control, and CAPAs at contract sites, including general assay troubleshooting support
  • Author, review, and approve assay qualification and validation study protocols and reports
  • Author relevant CMC sections for drug substance and drug product regulatory filings
  • Participate in the development of product specifications
  • Routinely report and discuss analytical results and conclusions both via oral presentation and in writing to colleagues and senior management

 

Qualifications:

  • Degree in Biochemistry, Biology, or Chemistry with 7+ years of relevant experience in the biopharmaceutical industry:
  • Analytical experience with biologics required, preferably with monoclonal antibodies
  • Experience in QC management is required, as well as strong skills providing technical leadership to outsourced contract organizations, supporting both testing and manufacturing. This includes directing method transfers, and design and execution of validation studies
  • Excellent problem solving and interpersonal communication skills
  • Must think critically and creatively, be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills

 

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.