ASSOCIATE DIRECTOR SUPPLY CHAIN 

PTx is devoted to developing and commercializing medicines and combination therapies that can make a meaningful difference in the lives of patients with cancer and other serious diseases. We are united in our passion for improving the treatment of cancer and other diseases and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.

 

PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art Northpointe (NP) manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. PTx is a small company full of opportunities and ambition and we need outstanding people to join our team to help realize our mission.

The Supply Chain function is responsible for the planning and inventory control of API / Bulk Drug Substance (BDS), Drug Product (DP), and Finished Product (FP).  Current focus is on the Leukine supply chain, however the department is also positioning itself to support future product acquisitions.  Supply Chain personnel generate Purchase Orders for fill and finish services in adherence to contracted terms and in keeping with sales/delivery forecast and supply targets.  Supply Chain personnel monitor and maintain production (fill and pack) and release (WIP) schedules and coordinate the timely movement, testing, and release of product.  Additionally, the department leads, sponsors, or supports supply chain projects, and ensures compliance with regulatory, finance, and corporate requirements.

POSITION OVERVIEW/KEY RESPONSIBILITIES:

  • Establishes and adjusts inventory level targets for BDS and FP, with input from stakeholders / S&OP team, per demand forecasts and production/business requirements.

  • Coverts commercial and clinical forecasts into supply and production plans; provides internal and external manufacturing (CMO) with requirements in accordance with internal processes and CMO agreements, respectively.

  • Provides scenario planning and modeling when requested.

  • Contributes to and participates in company S&OP meetings.

  • Serves as primary POC for CMOs for planning, scheduling, transportation, as well as overall business relationship.

  • Ensures CMO and 3PL Business Review meetings are held, content and metrics are relevant and appropriate, and actions are tracked through to completion.

  • Ensures WIP is monitored, prioritized, and expedited (when needed) in alignment with business needs and strategy; ensures issues are escalated, and plans for remediation are established and tracked through resolution.

  • Ensures master schedules for product fill, pack, and WIP are maintained and published.

  • Ensures PTx adheres to CMO supply/service agreements, and monitors CMO’s for similar adherence.

  • Generates Purchase Orders for CMO fills and packs, and reviews invoices for correct pricing; monitors performance and negotiates credits for rejected product.

  • Assists with management and rotation of the US government-owned FP inventory at 3PL site.

  • Monitors expiry dating of BDS and FP, identifies potential risk inventory, and works with the S&OP team to minimize write-off.

  • Ensures proper inventory control of BDS, DP, and FP at all locations, and ensures transportation of product is sufficiently controlled.

  • Authors and revises department SOPs; documents Deviations and CAPAs and initiates/leads Change Controls (e.g., new labeling) as required.

  • Leads functional area in ERP implementation, interfaces and process improvements.

  • Leads or contributes to projects associated with the supply chain (e.g. new locations, new products, new country approvals).

  • Participates on teams for establishing or integrating new products / CMOs into the PTx systems and processes.

  • Manage and provide guidance and coaching to direct reports focused on planning, WIP monitoring, inventory control and transportation.

  • Establish and manage departmental budget.

  • Establish and report department metrics, and incorporate continuous improvement initiatives into department operations.

LEADERSHIP QUALIFICATIONS: ☐ N/A if this position does not have direct reports.

  • Effectively collaborates with VP and director level stakeholders to achieve company objectives and to meet product-specific project milestones.

  • Effectively partners with CMOs and 3PLs in pursuit of positive outcomes for the company.

  • Effectively leads teams and partners with QA, QC, and other internal departments, with clear organization and timely communication.

  • Effectively leads staff by providing management oversight, communicating objectives, setting expectations, managing performance and providing coaching to foster employee growth.

BASIC QUALIFICATIONS:

  • Bachelor’s degree (or equivalent) Business or Science

  • 8+ years:  Supply Chain experience in regulated pharmaceutical environment

  • 10+ years: Planning/scheduling, supply analysis, material control in SAP or equivalent system

  • 5+ years: Employee supervision or management

PREFERRED QUALIFICATIONS:

  • Ability to monitor multiple parameters and recognize atypical events which may impact supply timelines. 

  • Ability to work well with personnel throughout the company to identify possible solutions to Supply Chain problems.

  • Ability to maintain a successful subcontractor relationship to overcome issues and challenges, holding CMO to contract agreements/schedules.

  • Experience with planning and scheduling in an ERP system.

  • Ability to ensure projects are completed on schedule and within budget.

Please contact Justin in HR for all inquiries at Justin.Hoeker@partnertx.com 

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(781) 218-9394

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19 Muzzey Street

Lexington, MA 02421

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