Associate Director / Director, Downstream Process Development
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.
This position is responsible for managing Downstream process development and subsequent manufacturing of biological products at Contract Development and Manufacturing Organizations (CDMOs). Management of CDMOs and CROs is a critical aspect of the job and will include frequent visits to the contractors depending on the intensity of the ongoing activities. The role involves significant cross-functional collaboration with other functions, including but not limited to - R&D Discovery, Upstream, Analytical, Quality Assurance, Toxicology, Regulatory, Project Management, and Executive Leadership.
These may include, but are not limited to, the following; other duties may be assigned:
- Manage and support Downstream Process development
- Manage and support Downstream manufacturing, Tech Transfer of Processes, Scale-up within or between CDMOs.
- Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CDMO/CRO, including tracking of technical risks, issues and decisions taken.
- Contribute to preparation and submission of CMC sections of regulatory submissions and updates (IND, BLA, and post marketing commitments)
- Design, manage and support Late-Stage BLA activities - Downstream Process Characterization Studies, Develop control strategies for process validation, PAI support.
- Author, review and/or approve Downstream and Virus Clearance related documents, including Batch Records, SOPs, Protocols, sampling plans, development reports, qualification/validation reports and other technical reports.
- Support process investigations and help determine root cause of excursions in clinical manufacturing.
- Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and procedures.
Education & Experience
- PhD in Biochemistry / Biology / Chemical Engineering, with 7+ years of biological process development and manufacturing experience with a strong record of achievement; or BS/MS
- Proven hands-on experience with purification processes such as Chromatography columns, membrane filtration systems, Ultrafiltration/Diafiltration, Final Fill etc.
- Proven hands-on experience managing and executing Virus Clearance studies
- Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
- Technical team management experience
- Experience of setting up a process development lab is a plus
- The position can be outside China location (may require travelling to China)
- Position may require working with biological and/or chemical hazards
Equal Opportunity Employer
Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant.
Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation.
Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.
Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.