Senior Product Development Scientist

BBI Group
Cardiff (Caerdydd)
£Competitive + Benefits
10 Aug 2017
19 Aug 2017
Senior Product Development Scientist Cardiff CF14 5DX / Crumlin NP11 3EF Permanent £Competitive BBI Solutions is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets. As a business, we are currently progressing through a substantial period of growth, and currently have the exciting opportunity for a Senior Product Development Scientist, to join our growing operation. This role will initially be based from our Cardiff site, but will move to our brand new Global Centre of Excellence in Crumlin, by early 2018. The Role As the Senior Product Development Scientist, your focus will be to lead and complete Product V&V activities within R&D projects as directed by the Transfer and Validation Manager. In addition, you will be required to support R&D projects within BBI Solutions, which will include the Project Management of smaller projects, small focused technical assessments, technical reviews and design reviews Your role responsibilities will include but not be limited to the following: Managing the Product Verification and Validation activities when required Generating project specific Verification Protocols and acceptance criteria Generating Stability Protocols in accordance with CLSI and ICH guidelines Training/ Leading/ Managing teams in the execution of verification and stability protocols Participatinf in Product Risk Management activities, lead V&V aspects Translating CLSI documents into workable Procedures and Protocols Sharing V&V knowledge and expertise with colleagues in Dundee and Cardiff Maintaining accurate and complete records of work Ensuring delivery of technical work within targeted timelines To work within local Health and Safety rules within the laboratories at BBI Work with colleagues to maintain good housekeeping in the laboratories and offices Maintaining technical documentation to fulfil requirements of DHF Writing technical reports for both internal and external circulation. Reporting technical progress to the R&D management and to customer The Person As the Senior Product Development Scientist, you will be a sound communicator, with the ability to build effective working relationships across departments. The abilities to work autonomously, manage tight deadlines and work under pressure will be paramount to your success. You will need to have a strong background in IVD development and verification & validation with a sound working knowledge of ISO9001 and ISO 13485, along with the following: Experience of working to Quality Management Systems Experience with ISO9001 and ISO13485 Experience of Verification and Validation activities for IVD’s. Experience in Project Management Experience of generating technical documentation for regulatory submissions The following is also desirable: Experience of 21 CFR Part 820 You will be somebody who has had training in producing verification reports and stability reports in line with relevant guidelines and an expert user of Analyse-it software. The Package The salary offering for this role is competitive and makes up part of BBI’s attractive benefits package, which includes: 5% contributory pension scheme. Life Assurance Private health care scheme. 28 days’ holidays (inclusive of bank holidays) with up to 4 additional days off, including 1 day for your birthday Participation in the childcare voucher and cycle to work schemes. The Company BBI is a fast-paced and agile business, with a track record of growth, and the opportunity to influence and direct the business going forward. We deliver exceptional products and technologies that people rely on to enjoy a better quality of life. We look for our people to be active participants in BBI life, to make work fun as well as challenging. This job was originally posted as