Director, Clinical Supply Packaging (Onsite)

Job Description

Position Overview -Basic Functions & Responsibility:

Global Clinical Supply (GCS) organization is within our Company's Research Laboratories and is accountable for managing the 'end-to-end' integrated clinical supply chain across all our Research & Development Division portfolio to enable the execution of any clinical trial using our Company's asset.  GCS supports more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced or run by partners as well as our Company's IIS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+countries, all in accordance with US and WW regulations, company policies and Standard operating procedures.

West Point site is the biggest site in our operations network. The packaging team plays a critical role in the clinical supply chain and flowless execution is paramount to meet the timelines and ensure business continuity for the portfolio. The Execution Operation head will be part of the WP CSO LT

The role is accountable of ensuring end to end operational excellence and execution in the packaging space of global clinical supplies executed in WP and is also accountable of the day-to-day management of the vendors supplying components and machinery necessary for execution of our products.

The Director will be a key part of WP CSO leadership team and as such will actively collaborate in update WP CSO strategy.

 As organizational leader the role will be accountable to shape packaging and distribution (execution center) organization to the current needs of the CS (Clinical Supplies) chain and our Research & Development Division portfolio.

Primary activities include, but are not limited to:

• Oversee all operations and packaging floor in buildings 78A and 69D; including reconfiguration of current space to maximize throughput, staff utilization to minimize errors, and ensuring audit preparedness at all times.

• Ensure efficient and compliant processes; including review and harmonization of all SOPs with WAG and Rahway. After harmonization, simplification and quality alignment to ensure agility and speed can be accommodated as required for the portfolio

• Controls scheduling activities and ensure collaboration across other GCS work center to enable business continuity and portfolio needs

• Talent attraction, development and retention

• Performance management; including utilization of existing P3 and P4 to begin managing contractor and our Company's CPT staff

• Capacity modeling and resource management; including presentation to LT and maintenance of metrics for each role within the packaging floor

• Oversight of execution of vendors in the component and machinery space in collaboration with cross-functional internal groups

• Close collaboration with Quality, Procurement, Finance, other GCS departments

• Alignment with WAG, including partner group interaction optimization (Distribution, LR, Ops Planning, Quality, Master planning, Bulk manufacturing, Analytical for cleaning/swabbing/investigations)

• Close collaboration with GCTO and Regulatory to ensure regulatory needs are included in the CFGs and on time arrival of our products are ensured right first time

• Seek ways to innovate and work smarter, removing barriers for the team and supports change as needed

• Lead a mixed team of our Company employees, union and contractors

Education & Experience:

• Bachelor's degree required in Engineering, Science or Operations Management, preferred.  An advanced degree is preferred but not required.  An MBA or other business degree, in addition to the required science or engineering education, is beneficial.

• At least 10 years of experience in Clinical Supply Chain and/or Clinical trials including exposure to Quality and/or continuous improvement activities.

• Understanding of clinical supply needs, experience in supply chain operations within a GMP environment.

• Strong understanding of cGMP, including FDA and EMEA requirements.

• Experience in packaging will be highly valued.

• Experience in leading teams, developing talent, mentoring or leading complex projects

Preferred Experience and Skills:

• Operations Management Certification (I.e., APICS)

• Six Sigma certification (i.e., Green or Black Belt).

• Project management, lean six sigma, detailed scheduling practices

• Able to organize a large team, upskill talent, and motivate for future success

• Comfortable with excel and Microsoft systems