Manager/Sr. 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 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:

• Review 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
• Assist in authoring 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                           biopharmaceutical industry: (BS 5+ years), MS (2-3 years)

• Analytical experience working with biologics required, preferably with monoclonal antibodies
• Previous experience in QC leadership roles 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
• Previous experience with stability review and trending
• 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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