-Supports Regulatory, Pharmaceutical Development, and Commercial project teams for Biological products throughout clinical development and commercial lifecycle-Develops a solid understanding of global RA CMC regulations and guidelines, and participates in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance-Interacts and effectively communicates with other internal and external colleagues-Executes and manages regulatory submissions globally-Helps define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements-Supports preparation activities for meetings with Health Authorities on CMC related matters-Ensures line management is apprised of developments that may impact regulatory success, communicating in a professional and timely manner-Evaluates change proposals for global regulatory impact with supervision and helps plan variations and amendments-Trains and mentors new colleagues on many different systems and internal processes in order to ensure seamless onboarding

-Maintain document plan/timeline •Develop TOC aligned with Regulatory CMC Strategy •Collaborate with Reg-CMC and content owners to prioritize and assign deliverables-Establish document structure •Create Virtual Documents and applicable templates-Author management •Drive meetings for kickoff, roundtables, content/ data reconciliation, and follow-ups •Lead RtQ process •Maintain content verification/approval workflow-Document management •QC, formatting, uploading, filing history, headers/ footers, linking, and folder/Vdoc structure •Document legalization, as needed-Issue resolution and mitigation planning activities-Manage submission readiness •Content verification and perform the final quality check-Prepare deliverables for support of submissions •Transfer TOCs •Provide Submission Ready documents to publishing •Archive necessary documents

Worcester site merged with the Shrewsbury site.- Act as Lead Auditor on designated projects- Perform internal audits under minimal supervision for both GLP small and large molecule (immunology) bioanalysis- Perform facility and process-based audits as assigned- Prepare and sign QA statement for inclusion in study final report- Report compliance issues to management- Responsible for maintaining the master schedule- Proficient with TrackWise and DEVIL2 (deviation information library)- Assist staff in the resolution of quality related issues- Assist with external audits and inspections- Independently host client audits- Provide GLP Orientation training to new hires- Assist in the training of newly hired auditors

- Act as Lead Auditor on designated projects- Perform internal audits under minimal supervision for both GLP small and large molecule (immunology) bioanalysis- Perform facility and process-based audits as assigned- Prepare and sign QA statement for inclusion in study final report- Report compliance issues to management- Responsible for maintaining the master schedule- Proficient with TrackWise and DEVIL2 (deviation information library)- Assist staff in the resolution of quality related issues- Assist with external audits and inspections- Independently host client audits- Provide GLP Orientation training to new hires- Assist in the training of newly hired auditors

(Previously Agilux Labs)- Independently perform routine and non-routine procedures for sample preparation for small molecule bioanalysis for pre-clinical and clinical trial samples in many different matrices under minimal guidance of a Principal Scientist- Proficient in SLE, SPE, Liquid-Liquid and Protein-Precipitation extractions- Responsible for ensuring that all raw data is recorded as accurate and complete as possible- Ensures that company SOPs and guidelines in accordance with GLP are followed- Ability to compile data and create data reports with minimal supervision- Assist in project management- Ability to prepare client emails for supervisors- Independently answer to and resolve all internal audit findings for all audits from the internal Quality Assurance group- Train and mentor junior staff with hands-on training for pipetting and for all types of extractions performed in lab- Efficiently manage workload for junior staff members- Experience in method development, method validation and sample analysis from start to finish- Ability to effectively communicate orally and in writing to coworkers and supervisors for identification of difficulties that may be discovered in various aspects of development, validation, extraction procedure or general sample analysis.- Proficient in LC-MS/MS (AB Sciex 5500, using Analyst and Aria software), including the infusion of compounds and trouble-shooting- Computer proficiency in Watson LIMs, Microsoft Word, Microsoft Excel, Analyst and other analytical instrumentation software

- Involved in performing bio-analysis of small drug molecules in many different matrices- Independently perform routine procedures for sample preparation and analysis under the guidance of a Principal Scientist- Proficient in SLE, SPE, and Protein-Precipitation extractions- Proficient in LC-MS/MS (using Analyst and Aria software), including the infusion of compounds and trouble-shooting- Responsible for ensuring that raw data is recorded as accurate and complete as possible- Train and mentor junior staff- Assist in project management- Ensures that company SOPs and guidelines in accordance with GLP are followed

- Proficient in SPE, DPX, and Liquid-Liquid Extractions to extract drugs from both a urine matrix and oral fluid matrix- Proficient in LC-MS/MS and LDTD instruments- Responsible for maintaining strict chain of custody- Experience with LIMs software- Ensures that appropriate testing procedures are conducted in compliance with QC and SOP requirements- Demonstrates GLP in accordance with CLIA guidelines

- Schedule sample preparation/digestions and instrument workload- Ensure that appropriate testing procedures are conducted in compliance with QC, SOP, and methodology requirements- Perform various digestion methods on environmental samples including waste waters, drinking waters, soils, dust wipes, air filters, and children’s toys in preparation for analysis- Perform extraction and filtration of TCLPs and SPLPs- Operate and maintain the ICP-OES, ELAN 9000 ICP-MS (LC/ICP/MS), and the FIMS 100 Hg analyzer, as well as analyze, report and review and the data generated- Monitor sample priority and perform preliminary review- Maintain clean and functional work areas, including maintenance of department equipment- Responsible for equipment maintenance and documentation- Assume supervisory role when necessary- Troubleshoot instruments, matrices, QC, and data reporting issues- Effectively communicate any resource allocation needs or issues