This position is on a 2 2 3 shift, 7a 7p. The Manufacturing Associate I/II Upstream is responsible for the execution of production activities for early and late phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II Upstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work is co

The Sr. Director, Manufacturing oversees the management of all areas of the Manufacturing department, including the upstream processing (cell culture and harvest), downstream processing (purification and bulk filling), and manufacturing support teams. The overall aim is to produce bulk intermediates and/or bulk drug substances while achieving quality, schedule, and cost o

s (Balanced Score Card) for self and team Leads or contributes to departmental initiatives as appropriate , including procedure development and improvement Cross site portfolio leadership OR process ownership; work with PMO and local team to continuously improve PM and project delivery practices. May own a PMO process, responsible for training tools and associated change m

The Senior Specialist has responsibility for the implementation of the Environmental, Health, Safety, and Sustainability (EHSS) program. This includes leadership to maintain EHSS compliance and continuous improvement. EHSS supports operations of biologic contract development and manufacturing organization. Responsibilities include incident response, reporting and investig

The Specialist has responsibility for the implementation of the Environmental, Health, Safety, and Sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manufacturing organization. Responsibilities include incident response, reporting and investigatio

The specialist has responsibility for the implementation of the environmental, health, safety, and sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manufacturing organization. Responsibilities include incident response, reporting and investigatio

Perform laboratory support functions such as sample log in and storage, issuance of controlled data forms, and monitoring of temperature controlled chambers in compliance with standard operating procedures, safety, and cGMP regulations. Responsible for all associated documentation and for maintenance of laboratory area. JOB RESPONSIBILITIES Manage cGMP system for incoming

This position is accountable for managing assigned inventories through daily, weekly, monthly, and annual physical counts. The Inventory Analyst organizes and partners in conducting periodic inventory counts, adjusts quantities and locations, records and reports discrepancies to management while maintaining communication with supported internal customers. Will be the lead

This position operates on a 2 2 3 schedule with the shifts 7a 7p. The Sr. Manufacturing Associate I/II Downstream is responsible for the execution of production activities for early and late phase Cell Culture programs within a GMP environment. The Sr. Manufacturing Associate I/II Downstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Addi

The Sr. Manufacturing Associate I/II Upstream is responsible for the execution of production activities for early and late phase Cell Culture programs within a GMP environment. The Sr. Manufacturing Associate I/II Upstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work is conducted following Good Manufacturi

The specialist has responsibility for the implementation of the environmental, health, safety, and sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manufacturing organization. Responsibilities include incident response, reporting and investigatio

Assist with and support execution of routine procedures within the manufacturing area. Position Responsibilities Order and stock general supplies in the manufacturing production areas Wash glassware/labware and clean equipment Perform GMP cleaning of suites as required Maintain records to comply with regulatory requirements, cGMPs, and SOPs The responsibilities of this po

KBI Is looking for a Process Development Associate for our Upstream team. The mammalian cell culture laboratories and pilot scale operations are state of the art. Single use bioreactors ranging from 15 mL to 200 L are employed for process development and tech transfer projects. Well characterized ambr15 and ambr250 bioreactors from Sartorius along with the Xcellerex Singl

This position operates on a 2 2 3 shift, with the hours of 7 00 am 7 30 pm. The downstream manufacturing associate will participate in the purification areas for a clinical and commercial GMP biopharmaceutical facility. The associates will perform production activities while safeguarding work environments, employing cGMP compliant behaviors, and following principles to en

This position operates on a 2 2 3 schedule with the hours of 7 00 am 7 30 pm. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure al