Manager, PX, GWE, LIS Lead

ROLE SUMMARY

This role will support a wide variety of analytical lab, pilot plant, process and utility equipment used in support of science and operations. This role will perform or manage the repair, maintenance and calibration of the instrumentation and equipment used at the Groton, CT site.

ROLE RESPONSIBILITIES

• Communicate with customers regarding service levels and lead the collaboration with science line equipment owners in creating service levels on new/existing GxP laboratory and clinical manufacturing assets

• Completes repair/maintenance and calibration tasks and work assignments to effectively manage asset life cycle requirements as well as the site colleague needs.

• Collaborate with stakeholders and Subject Matter Experts (SMEs) to establish support models for incoming and outgoing assets

• Communicate with management

• Collaborate with others to provide service to the site, this may include hard service providers, external service providers, equipment owners, vendors, procurement, etc.

• Participate with other site leads or team members

• Other related assignments as identified by GWE management as deemed appropriate.

• Collaborate with other sites to develop robust programs while driving alignment across the sites.

• Ensure compliance (regulatory and safety) during operations.

• Maintain site compliance readiness at 100%.

• Manage external providers to deliver services in accordance with site and customer requirements.

• Manage contracts, service agreements, etc. associated with external vendors utilized to provide support.

• Track and manage cost associated with services. Provide input to budget and support to meet budgetary goals and requests.

• Perform tasks in a compliant and efficient manner using metrics and Reliability Based Maintenance techniques where available.

• Remain current with regulations and service models to meet those regulations.

• Serve as the key source of GWE (Global Workplace Experience) Laboratory Instrument Services (LIS) knowledge by providing the necessary support for all compliance activities including but not limited to regulatory body audits, change control, training, and documentation. Drive changes in the program related to audit findings or changes in strategy to support customers.

• Provide project support related to assets.

• Use Subject Matter Expertise (SME) knowledge to determine make versus buy service strategies based on appropriate cost/benefit analysis.

• Set expectations and manage delivery of services provided by contingent staff.

• Perform monthly cost allocation for parts utilized in asset maintenance.

• Provide mentoring and training to both junior colleague and contingent staff.

BASIC QUALIFICATIONS

Education and Experience:

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• Degree in engineering or scientific discipline, technical certification or equivalent work experience

• Experience with asset support in a supervisor or leadership role

• Minimum of 2 years of work experience in laboratory environment

Technical/Job-Related Skills:

• Possesses a strong understanding of troubleshooting and repair

• Coordinate efforts of several groups of individuals

• Communicate effectively to diverse audiences

• Drive change and hold others accountable

• Exceptional people skills

• Strong verbal and written communication skills

• Initiative-taking/self-starter with ability to multi-task and work effectively with minimal supervision

• Proficiency with the Microsoft Office Suite of computer programs

PREFERRED QUALIFICATIONS

• Bachelor’s degree in engineering or scientific discipline, technical certification or equivalent work experience

• Demonstrated knowledge of the pharmaceutical including R&D laboratory and clinical manufacturing operations

• Understanding of FDA and GxP requirements and the drug discovery and development process

PHYSICAL/MENTAL REQUIREMENTS

Due to the nature of work assignments, the Laboratory Instrument Services (LIS) Manager must be able to perform detailed work on multiple, concurrent tasks, with frequent interruptions and under time cons