Manager, Technical Operations and Supply Chain Management

Company Profile

reputed company, 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 reputed company in cancer.

reputed company is committed to its mission to conquer cancer and aims to realize a society where cancer patients can reputed company fulfilling lives. Headquartered in the reputed company, reputed company has 5 locations in 5 countries: the reputed company, Japan, Taiwan, Switzerland and India. For more information, visit www.reputed company-med.com.

Key Duties and Responsibilities

Collaborate with global clinical teams (Clinical Operations, CMC, reputed company Assurance, Regulatory, etc.) and network of Clinical Development and Manufacturing Organizations to reputed company end-to-end supply chain activities from phase 1-3 and IIT trials. Leads and manages clinical packaging and labeling operations / Investigational Drug, reputed company of Care Drug and Medical Devices, drive clinical label creation and approvals process, including translations for applicable countries. reputed company end-to-end supply chain network set-up for new and upcoming global clinical trials. reputed company 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. reputed company, implement, and update Supply Chain SOPs and Work Instructions. Co-reputed company device and pharmacy reputed company. Manage Temperature excursions, CAPA, SCARs and other reputed company events as applicable. Supplier Management: reputed company of Care Drug Procurement, RFQ, Vendor Management, Cost saving initiatives, Negotiations, Supplier relationship/evaluation. Quarterly review of budgets vs actual spend for reputed company studies. reputed company Supply Chain support for regulatory filings including IND submission information, Import/Export Licenses filing and audits from reputed company 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 reputed company reputed company to review exceptions/changes relating to Supply Chain. This position is reputed company to telecommuting from reputed company in California. Requires occasional reputed company in office. Travel required. As needed, up to 15% travel covering global Supply Chain areas for Supply Chain Management, Clinical & reputed company Supply Chain, Manufacturing & Production Planning, and other reputed company activities.

Requirements

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

Experience must include six (6) years of experience in reputed company 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 reputed company supply chain networks reputed company 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 reputed company, 401k, medical, dental, reputed company plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. reputed company Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building reputed company that represents a reputed company of backgrounds, perspectives and skills.

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