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

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 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

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 is on a 2 2 3 shift, 7a 7p. The 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 Manufacturing Associate I/II Downstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work i

Responsible for directing and overseeing microbiological programs and methods activities for processes, instruments and equipment. Ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels. This person is responsible for the aspects of the following programs as directed by management Environmental Monitor

This position is on 2 2 3 shifts, 7p 7a. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment. The Manufacturing Associate I/II Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally, must ensure all work is conducted fol

The incumbent will support GMP manufacturing operations for late phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. The employee will support operations during the execution stage b

We are looking for a Lab Systems Support Analyst for our new, state of the art manufacturing facility being built in Geneva. In this role you would be joining a small, rapidly growing and highly motivated team setting up the busines in Geneva while drawing on the support of your colleagues in the US and Europe. What you’ll do You are excited at the prospect of joini

Oversees the management of all areas of Upstream manufacturing (media preparation, cell culture and harvest steps) and related Specialist support teams involved in producing drug substances with the aim of achieving schedule, quality and cost objectives. JOB RESPONSIBILITIES Lead Upstream staff hiring, oversee training and lead staff evaluations. Develop an engaged and hi

The manufacturing support manager will oversee the management of the manufacturing support activities in support of the startup and production at a new clinical GMP biopharmaceutical manufacturing facility. The individual will lead the manufacturing support team with the aim of achieving superior quality, safety, productivity and cost objectives. The individual will lead