Job Description Device Development Principal Scientist UK 09 R5
At Pfizer, we’re driven to improve the lives of people right across the globe. So bring your passion to one of the world’s premier biopharmaceutical companies -
and help us solve some of today’s most complex health challenges. It’s your chance to take ownership of your professional success and career development, with all the support you need to build an outstanding future with us.
As a people-focused business that’s been ranked Top Employer’ by the Top Employer Institute* for three years running, we can offer plenty more too.
As a Device Development Principal Scientist drug delivery device development in Pfizer’s DCoE, you will act as technical expert for of Drug Device projects for biologics and biosimilars.
You will work closely with project managers, compliance, regulatory CMC and QA and be the technical expert for test method development and validation, equipment qualification / validation, design verification, design review, device and process characterization etc.
You will also help define, utilize and leverage appropriate test method technology and ensure that device developers and suppliers adhere appropriate pharma and device regulations and control the quality of technical documentation.
o As technical expert, work closely with external vendors and internal partners to lead the following activities : design verification, shelf life and shipping study for drug delivery device
o Develop overall analytical control strategy to provide thorough product and process understanding to ensure that incoming, in-
process, and release meet specification requirements for clinical and commercial manufacture
o Apply scientific and engineering expertise and research experience to solve problems creatively and independently.
o Develop and validate test method and lead bespoke test equipment development
o Assist preparation of regulatory submissions, internal and external audits
o Perform statistical analyses of data to support decision making
o Plan own tasks for to ensure timely completion
o Mentor and supervise junior members in the team
Education, Skills & Experience
o BSc or BEng+ minimum 5 years’ experience in drug delivery device development
o Good communication skills and ability to work independently as well as in a team environment
o In-depth statistical data analysis skills
o Working experience of test method development and validation
o Good knowledge of mechanical and / or electronical testing of drug delivery device
o Preferred deep Knowledge and application of following standards in the work experience - Guidance, Design Controls, ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149 and ISTA 2 serie
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.