Associate Director, Supply Chain - Distribution and Logistics

Job Summary

Job Description Summary:

The Associate Director, Supply Chain - Distribution & Logistics leads the market launch readiness and expansion planning with distribution partners and transport providers. This includes managing existing distribution of Commercial product, clinical trials, and research and development materials in compliance with internal procedures, global import and export requirements, DOT /IATA regulations, GxP requirements across PTC regions.

The incumbent leads projects and collaborates with PTC internal departments and third-party vendors (including, but not limited to, Contract Manufacturing Organizations (CMOs), Contract Distribution Organizations (CDOs) shipping agents, and customs brokers to ensure the availability of Commercial Product, research and development materials, and clinical shipments with the US and internationally.

This individual may manage direct reports.

The Associate Director, Supply Chain – Distribution & Logistics supports adherence to relevant regulatory requirements, and company Standard Operating Procedures (SOPs) as appropriate.

Job Description

ESSENTIAL FUNCTIONS

Primary Duties/responsibilities

• Leads US Supply Chain readiness and set up across the PTC distribution network for new product launches and supports expansion to new territories.
• Leads the assessment and introduction of new 3PL’s/transport providers across US Supply Chain, to include the RFP process, assessment of vendors, approvals, contract negotiation and onboarding.
• Interfaces with Supply Chain Technical Operations launch team to coordinate distribution setup activities relating to new product introductions.
• Leads and coordinates shipping activities across CMC stakeholders, external logistics providers, PTC supply chain partners, customs brokers and related parties of samples, API’s, raw materials, intermediates, semi-finished and finished goods for development, pre-clinical, clinical, and commercial use to and from domestic and international locations.
• Develops and maintains strong relationships with cross functional stakeholders across the supply chain.
• Manages the supply and distribution of existing commercial products from the primary distribution center to pharmacies, hospitals, wholesalers, and customers internationally; interacts with these customers to monitor supply operations and to troubleshoot when required.
• Interacts with CMOs, manages relationships with CDOs and transport providers to ensure the timely shipping and delivery of inventory; coordinates and implements the logistics activities associated with the international and domestic transportation and distribution of PTC’s products.
• Facilitates and supports routing order management including general support for all orders processed in pre-defined markets and supports local regions in relation to customer approval, orders and general enquiries.
• Ensures documentation relating to customs clearance and supply authorizations is obtained for all orders and that no delay is incurred due to inaccurate documentation.
• Leads the new customer approval process including coordinating the onboarding of new distribution partners and pharmacies as per internal procedures.
• Creates documentation to supply order management and supply chain processes. Manages logistics flow and transport to work in progress (WIP) and finished products.
• Supports supplier management of PTC distribution centers including, but not limited to, management of queries, support of all orders (including approval of orders), set-up and approval of new customers and measuring of Key Performance Indicators (KPIs) to drive performance for on-time and full-delivery performance.
• Manages the documentation of quality issues related to supply chain procedures, including but not limited to risk, Risk Assessments, Change Controls, Deviations, CAPAs and SOPs.
• Prepares and / or reviews shipping documentation ensuring accuracy and compliance with customs requirements and trade regulations for domestic and international shipments. This includes commercial invoice, USDA memo, FDA memo, End Use Letters, statements required by other regulatory agencies, and other documentation as may be required.
• Manages the internal data repositories for shipping documentation and related information in a compliant manner.
• Develops and delivers periodic training for internal stakeholders in shipping processes to minimize errors. Routinely updates training materials to ensure continuous improvement.
• Interacts with transport providers to resolve issues and clear bottlenecks to ensure the timely delivery of PTC products and materials for domestic and international shipments.
• Supports logistic activities related to new product launches and special shipments by writing transportation protocols to qualify product transport and shipping lanes.
• May manage, coach and mentor direct reports.
• Performs other tasks and assignments as needed and specified by management.
  
  

Knowledge/Skills/Abilities Required

• Minimum level of education and years of relevant work experience.
• Bachelor’s degree or higher in engineering or a related technical discipline and a minimum of 7 years of supply chain, logistical or manufacturing experience in a pharmaceutical, biotechnology, manufacturing, or related environment.
• Special knowledge or skills needed and/or licenses or certificates required.
• Demonstrated ability to set up GDP Distribution requirements for market/region set up/expansion.
• Demonstrated ability to manage relationships with internal team and members and external vendors.
• Ability to manage and lead projects with a high degree of complexity.
• Strong working knowledge in Good Distribution Practice (GDP) in the pharmaceutical industry or related field, HTS classifications, U.S. import and export regulations, Hazmat shipping requirements, DOT / IATA requirements, Safety Data Sheets.
• Working knowledge of import and export requirements and trade compliance requirements in major geographies including US, Asia, Latin America, and European Union.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Special knowledge or skills and/or licenses or certificates preferred.
• PMP certification
• Travel requirements
  
  

10%

Office based position

EEO Statement

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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