Sr. Director, Supply Chain Operations - San Diego, CA | Biospace
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Sr. Director, Supply Chain Operations

Ignyta Inc

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Location:
San Diego, CA
Posted Date:
7/13/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Pharmaceutical, Supply Chain,

Job Description

Responsible for all aspects of pharmaceutical supply chain management including strategic sourcing, procurement & materials management. The role spans R&D and Commercial Ops, encompassing of clinical and commercial supply planning and procurement of materials, third party logistics and contract management; coordination of product flow through supply chain; materials management system setup and maintenance; invoice and PO tracking, inventory management; and monthly and annual reporting.


Duties & Responsibilities:


Core duties include the following. Other duties may be assigned.



Commercial Supply Chain Management.



1.     Implement material requirements and forecast planning tools to support launch, sustain supply, and optimize production and distribution inventories.

2.     Work closely with project team members (e.g. project management, CMC, Quality, clinical, commercial) and CMOs to create procurement, manufacturing, packaging and distribution plans (to include import/export).

3.     Participate in the selection and management of third party logistics (e.g. 3PLs, specialty distributors, SPPs)

4.     Develop processes and plans to achieve the production and supply chain objectives associated with the launch and sustainable supply of new products.

5.     In collaboration with CMC and Quality manage supply from manufacturers, packagers and third party logistics suppliers and contractually adjust production plans to meet fluctuations in product demand.

6.     Manage and document raw material, in-process and finished goods inventory levels at contract manufacturing, packaging and third party logistics suppliers.

7.     Issue timely updated drug product and API forecasts and corresponding purchase orders to contract manufacturers.

8.     Participate in the identification, assessment and selection of raw material and commercial manufacturing suppliers. Support Quality with audits of CMOs.

9.     Work closely with Regulatory Affairs and Quality to ensure that all regulatory requirements impacting the commercial supply chain operations are fully understood and proactively addressed (e.g. DSCSA – serialization).

10.  Assure that returned, expired and obsolete materials are appropriately tracked, dispositioned and processed.

11.  Contribute to the development, implementation, and maintenance of systems for reporting and monitoring commercial supply chain deliverables and efficiencies, and other supplier performance metrics.

12.  Oversee the tracking of purchase orders and invoices for commercial supply chain operations to meet the needs of the Finance department.

13.  Develop and manage budgets for the above activities.

14.  Create and manage the development of contracts, policies and SOPs as needed.



Clinical Supply Chain Management.



1.     Proactively coordinate the demand forecast, supply plans and inventory to assure on-time, reliable delivery of clinical trial materials (API and DP) to all global clinical sites aligned with project objectives.

2.     Manage the logistics and execution of CTM pack, label and shipment activities in compliance with contemporary quality and regulatory requirements.

3.     Determine and execute a strategy for ensuring sufficient availability of clinical trial material. Periodically review and implement continuous improvements to scale and adapt to portfolio demands and business needs

4.     Manage an integrated Clinical and Manufacturing forecasting and planning system to forecast CTM demand and assure alignment and appropriate timely delivery of CTM to enable project objectives.

5.     Work closely with Clinical, Quality, CMC (API, DP and Analytical), and Regulatory Affairs to ensure that all project specific quality, cGXP and regulatory requirements impacting supply chain operations are fully understood and proactively addressed (e.g. Import/Export regulations).

6.     Oversee supply chain operations to ensure no stock outs. Optimize supply chain costs, balancing with time and quality, and ensure redundant supplier relationships for all critical supplies.

7.     Assist in the development and negotiation of long-term supply agreements with critical API and drug product depots and distributors.



Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.




Requirements

Education / Experience:

•Bachelor’s degree, preferably in life sciences, business/economics or related field
•Minimum of 10 years of professional experience in life sciences supply chain and logistics functions, including at least 5 years working with small molecules.

·         Proven experience of building and directing a supply chain function to support and manage a new product launch.

·         Track record of managing pharmaceutical clinical material supply across multiple programs and jurisdictions (US and ex US)

·         Implementation of supply chain risk mitigation program to resolve single source, limited capacity & end-of-life materials deficiencies.

·         Process improvements in on-time delivery, cycle time, contracts etc

·         Strategic sourcing and contract negotiations.

·         Understanding of and adept in the use of contemporary forecasting tools, IT inventory tracking and data aggregation systems, to perform demand forecasts, cost analyses and other operational analyses

·         Familiarity with the oncology therapeutic area is a plus.

·         International distribution experience is a plus.