Senior Manager/Associate Director, Upstream Process 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.
Leap Therapeutics is seeking a motivated individual with substantial upstream process development and manufacturing experience with biologics to be part of a growing oncology company. They 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
The successful candidate will have responsibility for the technical oversight and leading projects of outsourced upstream process activities including cell line and cell culture optimization, process characterization, validation, and upstream GMP manufacturing of monoclonal antibodies at top tier external contract development and manufacturing organizations (CDMO).
They will collaborate with various internal functions including 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.
Specific responsibilities include:
- Lead development efforts for upstream process development, optimization, validation, tech transfer and GMP manufacturing activities at top tier CDMOs for 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.
- Participate in batch release with QA and QC including the review of batch records and supportive data.
- Provide technical input for the resolution of investigations, deviations, out-of-specification/out-of-trend, change control, and CAPAs at contract sites.
- Author relevant sections of IND/IMPD regulatory filings
Education / Experience / Skills:
- Minimum of B.S. in biology, bioengineering, biochemistry, or equivalent
- 5 to 7+ years (depending on education) of progressive hands-on experience in upstream process development, tech transfer and GMP manufacturing of monoclonal antibodies in the pharmaceutical/biotech industry.
- Strong expertise in the cell culture fundamentals and engineering principles needed to develop, optimize, scale-up, and transfer the upstream manufacturing processes.
- Experience working with external CDMOs.
- Process validation experience in support of late-stage clinical programs preferred (DoE, IQ/OQ/PQ)
- Knowledge of cell line development and cell banking
- 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
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.