Rakuten Aspyrian, Inc., is a privately funded clinical stage biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.
Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.
Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study for ASP-1929 to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy of ASP-1929 in patients with other cancer types.
Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.
Position Summary
Aspyrian is currently looking for a highly motivated individual to support cell culture process development, manufacture, and technology transfer to CMOs. This candidate will join Aspyrian’s CMC team focusing on various aspects of upstream cell culture process development, process characterization, technology transfer and research material generation. In addition, the ideal candidate will be familiar with processes related to the development, characterization and manufacture of antibody drug conjugates (ADCs).
Key Duties and Responsibilities
- Key responsibilities include the development, optimization, technology transfer, scale-down model development and process characterization of upstream cell culture and conjugation processes
- Participate in cell line development activities for material generation as needed to support analytical development, formulation development, stability programs, and in-vivo animal studies
- Provide support for transient gene expression activities including, purification and conjugation of critical research reagents
- Candidate will be responsible for the maintenance, calibration and troubleshooting of all cell culture related equipment to support development activities and small-scale material supply efforts
- Responsible for the 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
- Support the expansion of an internal cell culture lab, including bioreactor selection and installation, as well as the incorporation of supporting analytics
- Participate and provide input into the optimization of workflows related to cell culture and conjugation 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 culture and conjugation 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
- Other duties as assigned
Desired Education, Skills and Experience
- BS/MS with >4 years of experience in upstream biopharmaceutical development, manufacturing, bioengineering or related discipline
- Experience working with recombinant proteins, antibody drug conjugates and related analytical techniques is required
- Experience in purification and filtration (tangential flow filtration, ultrafiltration and diafiltration) operations highly desirable
- Understanding of cGMP manufacturing and associated regulatory requirements
- Experience with monoclonal antibody processes through development, clinical and commercial scales is preferred
- Statistical understanding of design of experiments (DOE) and the resulting datasets is preferred
- Understanding of non-antibody processes and regulatory experience is desired
- 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
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 Aspyrian 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.