Include ( but are not limited to ) Manage day to day prioritization of routine, in process, stability and finished product testing. Manage day to day support of operations related to environmental monitoring and monitoring of critical utilities. Lead training of all new employees and maintain all training documentation via current system. Support the EIR system and assist

Include ( but are not limited to ) Perform sampling of water and pure steam to support manufacturing activities. Perform Environmental Monitoring of isolator and supporting areas. Perform Compressed Air and Gas Sampling and Testing. Perform bioburden testing of water an in process samples to detect microorganisms and to obtain information on types and levels of microbial c

Include ( but are not limited to ) Perform sampling of water and pure steam to support manufacturing activities. Perform Environmental Monitoring of isolator and supporting areas. Perform bioburden testing of water an in process samples to detect microorganisms and to obtain information on types and levels of microbial contamination. Perform Total Organic Carbon, Conductiv

Include (but are not limited to) Manage day to day prioritization of routine, in process, stability, and finished product work. Supervises lab personnel, including staff performance and creation of staff schedules to ensure over time/weekend coverage for manufacturing support. Work with management to maintain working schedule of all work flowing through the QC Analytical L

Include (but are not limited to) Provide leadership to QC Microbiology Managers and senior personnel. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring. Ensure adequate QC support of GRAM operations across all shifts, including occasional weekend support. Develop and maintain resource plans addressing personnel, facility, an

Include (but are not limited to) Provide support to the manufacturing team when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling duties as needed. Oversee operations in cleanroom environment and communicate with supervision to devise appropriate resource delegation plans. Assist personnel on troubleshooting and

Include (but are not limited to) Coordinate and oversee process validation activities (PPQ). Prepare appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities. Conduct validation studies. Utilize risk assessment to identify critical areas for validation and generate test

Include (but are not limited to) Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation in support of GRAM and client driven projects including Standard Operating Procedures; Test Methods; Raw Material, Component, and Finished Product Specifications; Risk Assessments including cha

Include ( but are not limited to ) Conduct the identification and transfer of manufacturing processes from early stage development through transition to commercial manufacturing. Conduct the identification and transfer of finishing processes (Terminal Sterilization, Inspection, Labeling and Packaging) from engineering through commercial finishing. Conduct new equipment and

Include ( but are not limited to ) Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance. Establish and maintain good technique with regards to working in classified areas (including gowning qualification). Review and approve executed

Include (but are not limited to) Provide supervision to Quality Specialists of various levels. Responsibilities include managing, motivating, coaching and mentoring. Ensure Quality support and oversight of Aseptic Operations across all shifts, including weekend support. Oversight and management of the batch record review processes. Review and assessment of non conformance

Include (but are not limited to) Lead the initiation, planning, execution, control and closure of tech transfer projects. Availability to flex schedule to host customers while onsite. Act as a liaison between customers and team members. Assist with the management of global customer relationships and programs. Facilitate new and/or perspective client visits. Serve as a liai

Include (but are not limited to) Lead the initiation, planning, execution, control and closure of tech transfer projects. Availability to flex schedule to host customers while onsite. Act as a liaison between customers and team members. Assists with the professional development of the Project Managers and Associate Project Managers. Assists with the management of global cu

Include (but are not limited to) Perform, lead, oversee or direct the operation of the metrology lab along with its staff and contractors. Policies & Procedures Develop, implement, and ensure adherence to the standards, procedures, and forms necessary to run a fully compliant metrology program and lab. Calibration Ensure that measurement instruments and equipment are accur

Include (but are not limited to) Provide support to the manufacturing team when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling duties as needed. Oversee operations in cleanroom environment and communicate with supervision to devise appropriate resource delegation plans. Assist personnel on troubleshooting and