In this exciting role within Process Solutions's Validation Services team, you act as both our internal and external senior consultant for Extractables and Leachables (E&L) services. In our fast-growing E&L organization you will support our three global E&L laboratories (USA, India, China) to provide best-in-class services to our pharmaceutical/biopharmaceutical customers. Testing includes, but is not limited to, analysis incorporating NVR, TOC, FTIR, RP-HPLC, HS-GC-MS, DI-GC-MS, and LC-qToF separation and identification techniques. The purpose of the testing is to support MilliporeSigma products in customer applications and to provide technical consultancy for the validation aspect of customer filtration & single-use processes. Leading global transformative projects such as method development or harmonization while utilizing strong project management and operational excellence practices. Successfully maintaining excellent relationships with the lab managers, local subject matter experts, and customer project managers.Maintaining current industry and regulatory knowledge to provide the team with the most up to date information related to E&L testing.Developing content and participating in thought leadership activities, such as speaking at key industry conferences.Leading responses to customer regulatory queries.Gathering, analyzing, and communicating customer needs and competitive intelligence.Acting as a consultant to our marketing organization (i.e., proposing new services, reviewing our positioning).



Who you are:




Preferred Qualifications:



A high-energy leader - able to drive a team to execute our mission and to support team members to collectively achieve excellent results in their respective areas of responsibilityClear communicator, both internally and towards our customers, with the ability to explain project benefits, plans, status, and business impact across the organizationA strong ability to work in a team environment and interface with various departments/geographiesVery strong organizational skills & project management experienceCuriosity and drive to succeed: individually and as a team; willingness to learn and lead by doingThe ability to solve problems and develop data driven resultsThe ability to multitask and handle different responsibilities simultaneously in a fast-paced environmentYou have worked in pharma or biopharma R&D or manufacturing departments with a focus in analytical chemistry (i.e., HPLC, GC-MS, LC-MS, etc.)A strong understanding of industry practices regarding filter and single-use system usagePreferred BS/MS in chemistry or related science discipline with a 5+ years of experience working in regulated biotech/biopharmaceutical industryExperience with the implementation and utilization of LIMS (Laboratory Information Management System)Fluent in EnglishOpen to occasional international travelThe position is based in Burlington, MA (USA)