Sr. Associate I/II – Analytical Formulation Development
We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company headquartered in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.
We are supported by investors that have the commitment to build a long-term company that integrates research, development and commercialization of cutting edge cancer therapies with the aim to transform cancer treatments. Our mission is “CONQUERING Cancer. For LIFE.”
We are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product will advance into Phase 3 pivotal clinical testing 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. 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.
The Sr. Associate I/II is a key member of the Analytical Formulation Development team and will be involved in supporting Rakuten Aspyrian’s research and discovery programs and CMC activities. The candidate will perform HPLC, CE, ELISA and LC-MS based methods for structural characterization of Rakuten Aspyrian’s first-in-class photoactivatable monoclonal antibody conjugates. The ideal candidate will have shown proficiency in hands-on analytical work and the ability to collaborate with third party testing organizations. Responsibilities include method development, routine testing, structure elucidation, structure/function assessment, and analytical support of conjugation, formulation, and development stability studies.
Key Duties and Responsibilities
- Perform analytical characterization test methods suitable to support in-process, drug stubstance and drug product testing that meets anticipated regulatory requirements for Aspyrian’s lead clinical candidate
- Provide analytical support for drug product formulation and conjugation process development activities
- Support development and qualification of state-of-the-art analytical methods for product quality and stability assessments
- Support upstream and downstream processes with sample management and data reporting
- Summarize, interpret, and critically evaluate analytical data. Present results at group/team meetings
- Maintenance and troubleshooting of laboratory equipment
- Responsible for preparation of analytical buffers, mobile phases and inventory of critical reagents and supplies
- 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
- Rakuten Aspyrian is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. As a key member of the Analytical Formulations Development team, the Sr. Assoc. I/II is expected to participate in operational and strategic discussions with the Technical Operations group
- Other duties as assigned
Desired Education, Skills and Experience
- Minimum of 3-5 years of analytical development experience with biologics
- B.S./M.S. or higher degree in a life or physical science
- Knowledge and hands-on experience with physicochemical characterization techniques (including but not limited to): HPLC (SEC, IEX, RP), mass spectrometry (intact mass and peptide mapping), and capillary electrophoresis (icIEF, CE-SDS)
- Experience with formulation development is a plus
- Excellent oral and written communication skills. The position will require preparation of written reports in support of development and/or regulatory filings
- Excellent interpersonal and team building skills
- Ability to work independently, analyse and work with attention to detail, process and prioritize sensitive complex information and problem solve
- Ability and willingness to travel at times up to 5% nationally and internationally, depending on analytical activities
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.