Posted

30+ days ago

Location

Waltham, MA

Description

About Oncopeptides:

Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells.  Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Oncopeptides’ US headquarters is based in Waltham, MA with an office in Los Altos, CA, and global headquarters is in Stockholm, Sweden. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.

The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com

Position Summary:

Oncopeptides Inc. are recruiting a US Supply Chain Manager. Oncopeptides, founded in Sweden in 2000, develops drugs for the treatment of cancer/hematology and is in a very exciting phase of development.

The US Supply Chain Manager is the key team member who will ensure supply of life saving medicine to patients in the US in compliance with GMP, state and, federal laws.

The Supply Chain Manager works closely with Oncopeptides Global Supply Team, QA, US commercial sales team, US vendors, Regulatory and Finance.

Ensure that Purchasing, Logistics and Inventory are optimized in the best possible way across the US commercial supply chain. Take measures and develop processes to mitigate against theft and falsification of finished product.

Essential Areas of Responsibility:

•Lead and coordinate the supply chain activities to US commercial supply

Plan and send Production- and Purchase orders according to Forecast, parameters in the ERP system and according to Business and Quality Agreements to ensure supply to US commercial market and maintenance of safety stock levels.

Manage US Supply Chain Activities in ERP system

Forecasting and production scheduling for US market

Inventory management at CPO and 3PLs.

Batch Tracking and reconciliation of stock from point of entry to US to end of life.

 Shipping coordination of bright stock between 3PL and CPO and finished goods to 3PL.

 Lead the phasing in of bright stock from a secondary drug product supplier into the US commercial supply chain, review packaging dimensions and take the lead in validation of subsequent packaging activities.

Conduct GMP/GDP oversight of selected vendors for commercial supply. Contribute to activities associated with GMP/GDP audits and regulatory inspections. 

Ensure appropriate filing and archiving of commercial supply related documents

Vendor selection, in collaboration with Global Supply, of appropriate vendors for storage, packaging, labelling and distribution within US.•

Lead the phasing in of bright stock from a secondary drug product supplier into the US commercial supply chain, review packaging dimensions and take the lead in validation of subsequent packaging activities.

Responsible for deviation reporting and participation in CAPA process with QA

Develop SOPs and Work Instructions for US Supply Chain processes.  

Responsible for compliance and point of contact for the importation to US of bright stock drug product, investigational products and API materials in support of the Global Supply Chain and CMC.

Contribute or lead the full implementation of Oncopeptides compliance of DSCSA track and trace in collaboration with Global Supply and Treacelink Team.

Minimum Education & Experience Requirements:

Minimum 5+ years in supply chain and or purchasing.

5+ years in life sciences industry related experience

Project Management, Pharmaceutical Development, Clinical and/or Commercial Supply Management desirable.

At least 3 years direct experience in clinical or commercial supplies environment  

5+ years’ experience with ERP systems

Experience in coordinating packaging supplies and GMP required  

Proficient knowledge of Microsoft Excel, Power point and Project software required

Recent working experience with NetSuite ERP, PCI, and Cardinal 3PL is a plus

Up to 10% travel (domestic)

Position is based in Boston, MA •Reports to Sr. Director, US Distribution and Tra



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