Sr. Specialist – 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. Specialist is a key member of the Analytical Formulation Development team and is responsible for supporting Aspyrian’s late-stage clinical program of a first-in-class photoactivatable monoclonal antibody conjugate. The ideal candidate will have shown proficiency in advanced analytical characterization techniques for antibody-drug conjugates and the ability to collaborate with CROs and other third party testing organizations. Responsibilities include method development and validation, structure elucidation, structure/function assessment, and analytical support of conjugation, formulation and development stability studies.
Key Duties and Responsibilities
- Manage and support late-stage method validation at CRO/CMOs for testing of in-process materials, drug substance, drug product, and stability
- Lead in proposing and implementing effective analytical control strategies, product specifications and identifying critical quality attributes related to drug substance and drug product manufacturing
- Provide an in-depth technical assessment on drug substance and drug product In-Process Control strategy and reduce compliance risk
- Lead OOS, OOT and investigations at drug substance and drug product analytical QC labs
- Create and review technical documents including analytical method development reports, qualification and validation protocols and reports, and standard operating procedures in compliance with FDA, EMA and PMDA regulatory requirements
- The candidate needs to be familiar with ICH, FDA and USP guidances
- Support late-stage process development, process validation and FMEA
- Perform analytical characterization test methods suitable to support in-process, drug substance 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
- Summarize, interpret, and critically evaluate analytical data. Present results at group/team meetings
- Maintenance and troubleshooting of laboratory equipment
- 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. Specialist 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 8-10 years of relevant industry experience in analytical development with biologics
- M.S. or PhD 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), capillary electrophoresis (icIEF, CE-SDS), and cell-based potency assays
- 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 such as IND amendments and BLA
- 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 10% nationally and internationally, depending on Technical Operation 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.