Director of Process Engineering - Not Specified, Not Specified

The announced job offer is made public by the firm: Kintec Recruitment and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Not Specified at the city Not Specified, in the country US - at this current ZipCode:

The information residing in this page is not directly announced by our websites, we help users in the intent of finding the jobs they want and redirect them back to jobs8 for apropriate applying to any of the jobs listed on www.greenenergyjobsonline.com.

ROLE : DIRECTOR OF PROCESS ENGINEERING ASSIGNMENT TYPE : PERMANENT HIRE LOCATION: MIDWEST OFFICE BASED OR REMOTE BASED ASSIGNMENT. CANDIDATE MUST BE NORTH AMERICA BASED DUE TO BUSINESS TRAVEL REQUIREMENTS. CLIENT: Biotherapeutics CDMO Our client are building a 100+ square feet greenfield site and are looking to secure the services of a skilled Director of Process Engineering. THE ROLE Candidate will be tasked with the construction of a greenfield bulk biological drug substance manufacturing plant, intended for phase three and commercial level manufacture of live biotherapeutic products (LBP). The successful candidate will require expertise in at-scale manufacturing processes (upstream and downstream) and technology transfer for microbial and or related systems. With a demonstrable expertise in regulatory compliance, process dynamics of new facility construction, the successful candidate will: Lead technical discussion with internal and external stakeholders across all aspects of design and development of manufacturing area and process Develop and build process understanding and expertise for microbial based fermentation and relevant downstream processes Build and develop process and production control strategies in support of facility readiness, regulatory approval, and future routine operations Be the technical authority, and as such interface with clients on developing manufacturing projects Play a lead role in the evaluation for design of production equipment, performing technical review, vendor selection, oversee installation and qualification (FAT, SAT) Active contribution to strategy development and ongoing evolution for process qualification and execution Project manage, with development group technology transfer and scale up of customer products Lead the department in the implementation and improvement of practices and procedures related to GEP, GMP, product and process quality, cost, and schedule adherence WHAT THE CLIENT ARE LOOKING FOR A Candidate with a relevant technical education and complimentary experience developed in the biological manufacturing industry - ideally in process of microbial fermentation, recovery, and purification in biological. Candidate will be a skilled technical leader/manager. As a technical authority, Candidate will be able to demonstrate a history in process development, technology transfer or large-scale manufacturing process including fermentation, centrifugation, filtration, and lyophilization for biological drug substances. As well as US FDA governance for biological drug substance manufacture. Candidate will be able to work independently and be self-motivated.