Company Profile

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

This position will provide and be directly responsible for a full range of Quality Assurance functions. The range of functions will support programs spanning development through late stage clinical and product commercialization. This will be primarily a GMP Product Quality role supporting the CMC and Supply Chain Teams. The position reports to the Director of QA (GMP and Validation) and directly supports the execution of Rakuten Aspyrian product and program objectives, requiring individual, team and department work contribution.

Key Duties and Responsibilities

· Interface with Rakuten Aspyrian Analytical Development, Technical Operations, Regulatory Affairs, Supply Chain, Clinical Operations and other disciplines in support of Rakuten Aspyrian goals and initiatives

· QA management of Contract Manufacturing Organizations (CMO)

o Master Batch Record Reviews and Executed Batch Record Reviews and Approvals; quality issue resolution, and batch disposition

o Ensure product meets all in process and release tests

o Ensure components, raw materials, starting materials, and third-party testing facilities are fit for the intended function

o Assess out of specification results and deviations, and resolve any issues to allow closure and the timely implementation of corrective actions (escalate as necessary)

o Ensure product is stored and transported at appropriate temperature conditions and per validated or qualified shipper

o Review any shipping excursions and ensure deviations are generated and material quarantined appropriately in the event of an excursion or other quality issue

o Responsible in full for adherence with the quality agreement provisions

o Ensure GMP compliance profile is maintained

o As required, review stability protocols, data and reports, and comply with annual stability commitments

o Ensure products meet established expiry dating

o Manage sample retention program and periodic re􀘜inspection activities and reporting as required

o Provide Quality input for process and method monitoring and annual product quality reports

o Support material review board meetings

o Interface with CMO on quality discipline activities and other matters

o Interface with CMO on regulatory inspections

· Review Vendor and Rakuten Aspyrian Quality System documentation such as deviations, NCMRs, OOS’, Investigations, CAPAs and effectiveness checks

· Prepare documentation for Material Review Board presentation and meetings

· Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements

· Review Stability data and work with Analytical Development and Regulatory Affairs to justify, document and assign expiration dates for clinical material

· QA Review and/ or approval of protocols and reports from vendors and Rakuten Aspyrian’s Research and Development, Technical Operations, and Analytical Development functions

· Perform vendor qualification risk assessments

· Vendor site visits and vendor audits

· Write audit reports, and follow up on observation close-outs

· Provide QA support for specification development and other analytical support as needed

· Provide slides and metrics to support Quality Management Review meetings

· Review chemistry, manufacturing and controls sections and summary sections of world-wide regulatory filings, amendments, supplements, annual reports and other submissions as needed

· Review and/ or generate Quality Agreements

· Clinical Operations Support:

o Review and approve packaging and labelling master and production batch records

o Provide input into clinical labelling content based upon the regulations governing region of distribution.

o Approve labels as required

o Review/assess temperature excursions

o Other clinical operation compliance activities as required

· Develop/revise/implement/adhere to departmental policies and procedures affecting Quality Assurance

· Assist with maintaining file organization within the Quality Department

· Remain in compliance with Training program

· Other duties as assigned

Desired Education, Skills and Experience

· Associate Degree or higher

· 10+ years of direct Quality Experience with increasing responsibilities and GMP knowledge

· Excellent organizational skills and ability to meet deadlines

· Exceptional self-management ability

· Up to 25 % of travel including international travel required

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.

This position has been filled. Would you like to see our other open positions?