Associate Director/Director, Drug Product Development, Manufacturing, and Supply Management

Leap Therapeutics is seeking a motivated individual with drug product development, drug product manufacturing (fill and finish), validation, and supply management experience within the biologics space to be part of a growing oncology company.

The individual 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 be responsible for the technical oversight and management of early and late stage drug product fill and finish operations, including; development, validation, and GMP fill and finish manufacturing of monoclonal antibodies at external contract development and manufacturing organizations (CDMOs).

He/she will collaborate with various internal functions including Analytical, Upstream/Downstream, Quality Control, Quality Assurance, Regulatory, Clinical Operations, and Supply Chain to ensure best practices are implemented and followed at external contract manufacturing and testing labs, and internally at Leap Therapeutics.


Specific responsibilities include:

  • Manage drug product development, optimization, validation, and fill and finish GMP manufacturing activities at top tier CDMO for late stage clinical supply through launch/BLA.

  • Co-author batch records, validation protocols/reports in collaboration with the CDMO.

  • Use creative problem-solving skills to independently troubleshoot experimental challenges - interpret data, define problems, establish facts, draw valid conclusions, and make decisions.

  • Assist with the trending of process development, validation, and manufacturing data for continuous process improvement.

  • Manage drug supply/demand forecasting estimates.

  • Manage operational budget and timelines.

  • As the Drug Product SME perform technical review of batch records and supporting data in collaboration with QA and QC for batch release.

  • Provide technical input for the resolution of investigations, deviations, out-of-specifications/out-of-trends (OOS/OOT), change controls, and CAPAs at contract sites

  • Author relevant CMC sections of IND/IMPD regulatory filings

  • Formulation experience is highly desired but not required.

 

Education / Experience / Skills:

  • Minimum of B.S. in biology, bioengineering, biochemistry, or equivalent

  • 10+ years (depending on education) of progressive hands-on experience in process development and GMP manufacturing of monoclonal antibodies in the pharmaceutical/biotech industry

  • Substantial experience with managing external CDMOs

  • Process validation experience in support of late stage clinical programs preferred (DoE, IQ/OQ/PQ)

  • Fill/Finish manufacturing experience is required

  • Advanced understanding of the application of FDA regulations and ICH guidelines from early development through commercial products

  • Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results

  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross functional personnel at all levels

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