LM Critical Reagents Operations Lead

Job Description

A robust analytical testing network is essential to realize our company’s mission and strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial products. The Associate Director, Large Molecule (LM) Critical Reagents (CR) Operations, is a leadership role accountable for compliant formulation/filling, labeling, storage, and distribution activities across internal and external facilities to realize uninterrupted customer supply of well-performing, qualified reagents and select analytical materials for our company's growing inline large molecule product portfolio.   

The LM CR Operations, Associate Director will lead a team responsible for the execution of material make, store, and ship activities in accordance with quality system requirements and dates established within cross-functional integrated work plans.  Materials within scope of this role include critical reagent source materials, intermediates, and finished reagent forms as well as certain defined analytical materials or samples that require formal control or execution coordination through Large Molecule Analytical Sciences (LMAS).  This role will have oversight of associated equipment/facility areas at the West Point and North Wales campuses and is responsible for maintenance of those areas in accordance with GMP/GLP requirements and operational best practices.   

Key responsibilities include team management, prioritization support through standardized tier processes, and utilization of metric monitoring to build and sustain a high performing team culture.  Key operational expectations include sustainment of real-time inventory accuracy and data integrity within and across LM CR Operations activities and nodes.  This role will coach the team to proactively identify and implement near term opportunities to standardize operations, maximize customer service levels, and improve operational efficiency while utilizing current systems and facility capabilities.  Additionally, this role will prepare the team for future ways of working aligned with in-flight capital investments to deliver a modernized LM CR Operational facility.   As leader of the Operations team, the LM Critical Reagents Operations Lead will routinely collaborate with leaders across LM CR to deliver shared priorities to reduce critical reagent supply risk for established and launching products.   

The ideal candidate for this position will have a strong working knowledge of material distribution compliance requirements and operational practices at the WP and NW sites.  Familiarity with GMP area operations and maintenance of GMP equipment/facilities in accordance with QMS requirements is required.    

This is a new role to integrate previously separate local teams at NW and WP into a single operating unit with harmonized practices, therefore strong communication and collaboration skills are required for engagement within team and with partners/stakeholders across the organization.   

Primary activities include, but are not limited to: 

As the LMCR Operations team lead, this role is accountable for the compliant and timely execution of activities supporting the preparation, storage, distribution, and logistics of LM CR qualified and controlled materials:   

• Ensure execution of reagent formulation/aliquoting batches and material transfers according to target dates according to Large Molecule (LM) Critical Reagents S&OP process and aligned cross-functional integrated work plans (issued/approved by the LM Critical Reagent Planning and Controls)   

• Participate and execute internal and cross functional strategic planning activities, Project planning activities, project prioritization activates 

• Ensure accurate and timely execution of work by teams under appropriate GMP and QMS conditions in accordance with appropriate guidance documents. 

• Ensures compliance and safety within the organization. 

• Establish and monitor KPIs for department performance both internal and external.   

• Develop and standardize best practice approach for business and operations supporting material storage, movement, and inventory system transactions and implement at WP and NW sites 

• Coach and develop team members to realize full leadership potential 

• Ensure employees are competent and qualified to perform duties. 

• Develop and maintain standardized