Senior Manager/Associate Director,

Analytical Development and Quality Control

 

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

 

They will 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.

 

 

General Responsibilities

The successful candidate will take the lead managing QC activities at external testing labs.  They will collaborate with various functions including process development, quality, regulatory, and clinical.

 

 

Specific responsibilities include:

  • 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 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

  • 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 the following years of relevant experience in the biopharmaceutical industry:  (BS 7+ years), MS/PhD (3+ years)

  • Analytical experience working with biologics required, preferably with monoclonal 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

  • Excellent skills required in the areas of analytical problem solving and interpersonal communication

  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills

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