Lead Process Validation Expert

Recruiter
Clinical Professionals Ltd
Location
London (Greater)
Posted
31 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Lead Process Validation Expert Berkshire Permanent £50,000 - £55,000 Our client is a leading Life Science supplier & manufacturer across a range of pharmaceutical products. They"e;re looking for a Lead Process Validation Expert who is a subject matter expert & is able to provide technical oversight of all aspects of process validation on-site and liaise directly with customers to ensure successful commercialisation of processes from lab to GMP manufacturing. Duties/Responsibilities: - Responsible for the technical oversight of commercialization process validation execution and direct technical SME's, validation via others, in Quality and Regulatory functions to ensure successful outcomes. - Responsible for customer interface within MSAT to technically develop and optimize process performance for productivity (yield and throughput) quality and cost. Represents the clients"e; site MSAT technical capability in preparation and execution of regulatory submissions. - Working cross functionally to implement to desired timelines on innovative and new process technologies. - Makes technical decisions and set the overarching strategy for the site and ensures successful transfer to manufacturing of projects identifying and resolving technical problems. - Contributes to the development and implementation of structured technical process validation training and sharing best practices at a team and site level to ensure continuous improvements in project tech transfer execution. - Proactively anticipates and evaluates trends of innovation within MSAT and technically lead site application and implementation including project management, working cross functionally to resolve barriers and delays. - Attends and represents the client"e;s scientific reputation at International conferences in areas of expertise to ensure external learning is maintained. Requirements: - The successful candidate will be educated to PhD level or equivalent level of years of experience in industrial positions, ideally in Biological Science or Biochemical Engineering disciplines. - Significant experience gained in process validation and manufacturing environment - preferably in mammalian cell manufacturing e.g. USP, DSP, purification development and process validation. - Have in depth knowledge, recognized SME in technical field of expertise i.e. process validation regulatory submissions, USP or DSP GMP operations. - Possess excellent interpersonal skills with ability to work cross functionally both with internal and external customers at all levels of the organisation. - Experience as a technical role model across multi functions at site level - Strong interpersonal skills with a proven problem solving mind-set who can multi task and successfully deliver. If however, you do not feel that this is the right role for you, please forward these details on as we do have a generous referral scheme in place. Please note, due to the high volume of applications, if you do not receive a response within 48 hours, your application has not been successful on this occasion. process validation, process transfer, manufacturing, cGMP, GMP, mammalian cell, upstream, downstream, USP, DSP, protein purification, regulatory submission, Berkshire, UK

Similar jobs

Similar jobs