Associate Director, CMC Downstream Development and ManufacturingShare to LinkedIn Apply Now Apply Now
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 GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
The successful candidate will assist in managing external drug substance and drug product development and external manufacturing sites. S/he will collaborate with various internal and external functions including process development, analytical, quality, regulatory, and clinical.
The role is within a highly collaborative team environment. S/he will assist in developing and implementing operational plans to meet project timelines and the company’s business objectives.
Specific responsibilities include:
Lead the development of robust purification processes utilizing multiple chromatography modes, filtration, and clarification technologies at CDMO site.
- In collaboration with CDMO design, optimize, and characterize downstream manufacturing.
- Draft documentation of all activities across all areas of responsibility process based upon quality by design (QbD) principles.
- Lead liquid drug product formulation development, technical transfer and fill at CDMO site.
- Lead the technical transfer, scale-up and manufacturing of biological drug substance anddrug product to support late-stage clinical studies.
- Interface with upstream, analytical, formulation, regulatory, QA/QC groups to ensure alignment with overall program objectives.
- Participate in designing phase appropriate viral clearance studies to enable regulatory submissions
- Draft supporting documents for CMC sections of regulatory submissions.
- Establish and maintain an understanding of current trends in purification technologies
- Set clearly defined goals/objectives with contract organizations to ensure delivery of high-quality results while maintaining timeline and budget.
Education / Experience / Skills:
- BS/ MS/phD in chemical engineering, biochemistry, or closely related field.
- 8+ years of relevant experience within a process development and/or technical transfer environment.Strong background and expert in purification unit operations from development to scale up: chromatography, filtration, harvest, and viral clearance validation Experience working with CDMO, oversee tech transfers, and authoring technical documentation such as batch records and agency submission.
- Experience with process characterization using DoE, data analysis, process validation, and Quality by Design concepts.
- Ability to understand the development lifecycle from R&D through commercialization.
- Working experience with drug substance regulation, and downstream process for biologics. Having formulation & drug product understand is a plus.
- 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.
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.