Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 4 countries, Japan, the Netherlands, and Taiwan. For more information, visit www.rakuten-med.com.
Rakuten Medical is currently looking for a highly motivated individual to support cell line and upstream process development activities. This candidate will join Rakuten Medical ’s CMC team focusing on various aspects of preclinical antibody development including transfection and single cell cloning, cell culture process development, late-stage characterization, technology transfer and research material generation.
Key Duties and Responsibilities
- Supporting development, optimization, technology transfer, and process characterization of upstream cell culture processes
- Participate in transient gene expression activities for material generation as needed to support analytical development, formulation development, stability programs, and preclinical animal studies
- Support early-stage antibody development; from initial cell line/vector development to GMP manufacturing
- Candidates responsibilities include the maintenance, calibration and troubleshooting of all cell culture related equipment to support development activities and small-scale material supply efforts
- Support preparation of buffers and media and other required reagents as needed to support in-house cell culture and conjugation activities
- Responsible for ordering and maintaining raw materials, lab supplies and providing oversight to inventory of all required reagents
- Responsible for operating benchtop bioreactors for process development, material generation and/or tech transfer activities
- Participate and provide input into the optimization of workflows related to cell line development and cell culture activities
- Candidate would participate in raw materials and/or equipment specifications, new equipment integration, new product integrations, and process data trending
- Participate in statistical design and analysis of process characterization and qualification activities
- Author technical documents and reports to support cell line development and cell culture activities
- Applicant should be an effective communicator of ideas and results to the team and should have the ability to proactively identify issues and suggest solutions in a collaborative multidisciplinary environment
Desired Education, Skills and Experience
- BS/MS with >1 years of experience in upstream biopharmaceutical development, manufacturing, bioengineering or related discipline
- Experience with monoclonal antibody processes through development, clinical and commercial scales is preferred
- Experience working with recombinant proteins, antibody drug conjugates and related analytical techniques is preferred
- Understanding of cGMP manufacturing and associated regulatory requirements is preferred
- Statistical understanding of design of experiments (DOE) and the resulting datasets is preferred
- Attention to detail, innovative thinking, and ability to work well in multidisciplinary teams is required
- Candidate must be able to work effectively communicate and present ideas and results in a cross-functional team environment
- Excellent organizational skills and ability to meet deadlines
- Exceptional self-management ability
- May require travel in support of Rakuten Medical’s development and manufacture campaigns. Travel time is no more than 15% annually.
Physical Demands of Job
This position requires lab work, frequent sitting, computer operation, standing, walking, talking, and hearing. The position may require travel in support of Rakuten Medical’s development and manufacture campaigns.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.
Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.