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Manager/Sr. Manager, Drug Product Manufacturing

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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 drug product manufacturing 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.

Overview:

The successful candidate will be responsible for the technical oversight and management of 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).

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

Responsibilities:

  • Implement and lead technology transfer & manufacturing for current and future drug products.
  • Manage drug product validation, and fill and finish GMP manufacturing activities at CDMOs 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 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

Qualifications:

  • Minimum of B.S. in biology, bioengineering, biochemistry, or equivalent
  • Fill/Finish manufacturing and validation experience
  • Experience with managing external CDMOs
  • Process validation experience in support of late-stage clinical programs preferred (DoE, IQ/OQ/PQ)
  • Experience authoring CMC sections in regulatory filings (IND, and IMPD) preferred
  • Understanding of the application of FDA regulations and ICH guidelines from early development through commercial products
  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross functional personnel at all levels

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.