Job Description

Why Patients Need You

Pfizer\xe2\x80\x99s purpose is to deliver breakthroughs that change patients\xe2\x80\x99 lives. Research and Development is at the heart of fulfilling Pfizer\xe2\x80\x99s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.

As one of the world\xe2\x80\x99s premier innovative biopharmaceutical companies, we\xe2\x80\x99ve discovered, developed and delivered over 100 different medicines, vaccines and consumer healthcare products. Products that help save and transform the lives of millions of people around the world every year. Now, we want you on board. We are looking for a Device Development Project Manger to join us and be part of our Devices Centre of Excellence (DCoE) in Cambridge, UK.

Working as part of a friendly, collaborative, capable and highly motivated group within the BioTherapeutics PharmSci Pharmaceutical Research & Development organisation (BioTxPS PhRD) managing the development of drug delivery devices and combination products. Programmes support the BioTx PS portfolio of early and late-stage assets as well as new devices for established Pfizer products already on the market. The position does not have line manager responsibilities.

We offer a competitive package plus a flexible working arrangement which we will be happy to discuss.

Position Summary

• To lead multi-disciplinary project teams in the development and life cycle management activities for drug delivery combination products.
• To liaise across Pfizer with drug product development and manufacturing teams, as well as external vendors to coordinate industrialisation activities
• To manage project activities to meet specified targets for quality, cost and schedule

Education, Skills and Experience

• Degree, HND or equivalent in relevant engineering or other technical discipline
• Extensive experience leading multi-disciplinary teams in the development of combination products or medical devices
• Experience of planning product development programmes from concept through to commercialisation.
• Experience with principles of device design control as well as knowledge of ISO13485, GMP, ISO14971, ISO62366 and global regulatory requirements such as EU Medical Device Regulations
• Experience in the preparation of device sections of BLAs, MAAs, INDs, IMPDs and CTDs for global markets.
• Excellent communication skills; capable of articulating ideas and concepts clearly and concisely with internal and external team members
• Knowledge and experience of project planning tools and techniques
• Knowledge and experience of mechanical, product or production engineering or other relevant technical discipline
• A practical, analytical, and pragmatic approach to work.
• Must be able and willing to travel globally in support of business and project requirements
• May be required to travel at weekends
• May be required to be away from home for a period of up to two weeks
• Must be able to drive
• Knowledge of using risk assessment tools including FMEA (Preferred)
• Knowledge of injection moulding (Preferred)
• Knowledge of automated equipment for assembly and/or testing (Preferred)
• Knowledge of medical devices, combination products, drug delivery products or needle injection systems (Preferred).

Work Location Assignment: Flexible

Purpose

Breakthroughs that change patients\' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let\xe2\x80\x99s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms \xe2\x80\x93 allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Research and Development

Pfizer