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 being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF-15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
The successful candidate will be responsible for the technical oversight and management of drug product fill and finish operations, validation, and GMP fill and finish manufacturing of monoclonal antibodies at contract development and manufacturing organizations (CDMOs).
They will collaborate with various internal functions including Analytical, Upstream/Downstream Manufacturing, Quality Control, Quality Assurance, Regulatory, and Supply Chain to ensure best practices are implemented and followed at external contract manufacturing and testing labs, and internally at Leap Therapeutics.
- Implement and lead technology transfer, process validation, and GMP manufacturing in support of Drug Product fill/finish for early and late-stage clinical supply through launch/BLA.
- Negotiate supply agreements, manage operational budget and timelines, and manage day to day activities at the CDMOs.
- 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.
- As the Drug Product SME, perform technical review of batch records and supporting data in collaboration with QA and QC for lot release.
- Support formulation development.
- 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.
- Minimum of B.S. in biology, bioengineering, biochemistry, or equivalent and 3-5 years of relevant experience in the biotech or pharmaceutical industry
- Experience with managing external CDMOs for Fill/Finish operations for early through late-stage biologics essential.
- 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.
- Excellent oral and written communication skills – outfacing role with internal/external partners and CDMOs.
- Understanding of the application of FDA regulations and ICH guidelines from early development through commercial products.
- Excellent interpersonal skills, personal integrity, professional manner, and an 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.