Manager, Technical Operations and Supply Chain Management

Company Profile

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 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Key Duties and Responsibilities

Collaborate with global clinical teams (Clinical Operations, CMC, Quality Assurance, Regulatory, etc.) and network of Clinical Development and Manufacturing Organizations to oversee end-to-end supply chain activities from phase 1-3 and IIT trials. Leads and manages clinical packaging and labeling operations / Investigational Drug, Standard of Care Drug and Medical Devices, drive clinical label creation and approvals process, including translations for applicable countries. Lead end-to-end supply chain network set-up for new and upcoming global clinical trials. Develop Supply Strategies and Inventory optimization plans per program, protocol design and region. Design, Implementation and UAT of Interactive Response Technology (IRT/IxRS) for multi-arm drug-device combination trials. Develop, implement, and update Supply Chain SOPs and Work Instructions. Co-develop device and pharmacy manual. Manage Temperature excursions, CAPA, SCARs and other quality events as applicable. Supplier Management: Standard of Care Drug Procurement, RFQ, Vendor Management, Cost saving initiatives, Negotiations, Supplier relationship/evaluation. Quarterly review of budgets vs actual spend for active studies. Provide Supply Chain support for regulatory filings including IND submission information, Import/Export Licenses filing and audits from all health agencies. Proactively report supply risk, product and material availability issues. Participate in and contribute to supply chain metrics, S&OP (Sales & Operations Planning) process. Drive Ad-hoc projects to review exceptions/changes relating to Supply Chain. This position is open to telecommuting from anywhere in California. Requires occasional presence in office. Travel required. As needed, up to 15% travel covering global Supply Chain areas for Supply Chain Management, Clinical & Commercial Supply Chain, Manufacturing & Production Planning, and other related activities.

Requirements

Master’s degree or foreign equivalent in Supply Chain Management, Industrial, Operations, Production engineering or closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).

Desired Education, Skills and Experience

Experience must include four (4) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Or an alternative Bachelor’s degree or foreign equivalent in Science in Supply Chain Management, Industrial, Operations, Production Engineering or a closely related degree and experience as an Associate Manager, Technical Operations & Supply Chain, Supply Chain Specialist, Clinical Supply Chain Coordinator or related occupation in supply chain management. APICS/ASCM Certification required (CPIM or CTL or CSCP).

Experience must include six (6) years of experience in all of the following:

1. Experience in global clinical supply chain management, medical device industry and developing/implementing clinical trial management technologies (eg: IxRS, IRT, etc.).
2. Experience in forecasting, supply planning, optimizing inventory, S&OP process, scenario planning, production planning & scheduling, CMO management, regulatory requirements relating to clinical labeling, packaging, and distribution activities.
3. Working under a highly regulated cGMP and GCP manufacturing environment.
4. Designing and setting up complex supply chain networks within strict FDA compliance, GLP, GCP and GDP frameworks.

Salary: $149,282.00 annually

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 for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. 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.