Manager, Analytical Development and Quality Control

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

 

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

 

 

General Responsibilities

The successful candidate will help manage QC activities at external testing labs for a Phase II clinical stage oncology molecule.  The role is highly interactive, collaborating with various functions including process development, quality, regulatory, and clinical.

 

 

Specific responsibilities include:

  • Assist with study protocol design, review and trend stability studies and lot release data for drug substance and drug product

  • Help 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

  • Help 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

  • Participate with authoring relevant CMC sections for drug substance and drug product regulatory filings, both US and ROW

  • Aid with the review and approve assay qualification and validation protocols and reports

  • Manage tracking of analytical reference standards

  • 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

 

 

Education / Experience / Skills:

  • Degree in Biochemistry, Biology, or Chemistry with 3+ years of relevant experience in the biopharmaceutical industry

  • Analytical experience working with biologics required, preferably with monoclonal antibodies

  • Previous experience working in regulated space (under GMP or GLP) is preferred, as well as experience working with outsourced contract research organizations supporting both testing and manufacturing

  • Excellent communication and interpersonal skills required

  • Must think critically and creatively and be able to work independently and have strong organizational skills

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