Oversees daily operations including formulation, filtration, filling and troubleshooting any issues. Batch record review and generation (Client calls and Project Management interactions) Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting. Client calls, interactions and meetings (kick off meeting, tours,

Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records. QMS process support for change controls and quality investigations. Performs AQL inspection of final filled product. Performs area line clearance operations in support of manufacturing operations. Provides QA oversight and performs real ti

Performs lab logistics functions including sample management, testing coordination, and shipping & receiving. Pipettes samples and applies barcode labels as needed for testing and shipping purposes. Responsible for monitoring and maintenance activities for all QC storage units, samples, and support equipment across several locations. Timely buffer and reagent preparation

Manages the review of records and associated data in support of GMP operations activities (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records) Assists in the review and approval of internal production batch records and associated data for product disposition. Performs the review and data entry for calibration, preventative mainten

Continually assesses the efficiency and effectiveness of executed technical documentation in support of the manufacture and testing of Drug Substance and Drug product. Oversees routinely scheduled functions to support CGMP processes. Champions CGMP activities by with oversight, guidance, and quality decision making. Appropriately leads and coaches direct reports in confid

Manages the review of records and associated data in support of GMP operations activities (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records) Assists in the review and approval of internal production batch records and associated data for product disposition. Performs the review and data entry for calibration, preventative mainten

Contributes to customer audit program, including scheduling audits, hosting audits, communicating and coordinating with internal SMEs, responding to audit findings, and tracking completion of corrective actions. Contributes to internal audit program, including generating an audit schedule, conducting audits, writing audit reports, and evaluating responses to audit observa

Supervision of Procurement personnel. Supports creation and implementation of category plans. Monitors purchasing systems and procedures and ensures compliance to company authorizations, policies, and procedures with respect to the purchasing function. Researches suppliers, pricing, cost effectiveness, and availability of material and commodities. Establishes and maintain

Responsible for development of project timelines and tracking of contract deliverables. Hosts project meetings to provide status update to clients and internal cross functional team members. Communicates effectively with client and across all functional groups so that schedules and scope of the project is clear. Identifies project issues such as resource, technical or sch

Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment. Performs various semi routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Troubleshoots manufactur