Based in Cambridge, this is a new senior Associate Director level Product Development Management position with a medium sized, globally based, pharmaceutical group. The focus of the role is to take overall responsibility for all development projects and programmes within the Medical Device portfolio including strategy and direction. The medical devices are used for dose delivery so there will be close collaboration with the pharmaceutical development teams.
The company is the research facility managing drug development exclusively for a globally based group that is collectively a medium sized pharmaceutical organisation. They offer the advantage of a smaller, supportive and collaborative company environment while working as part of a larger, global organisation. With around 200 people in the Cambridge headquarters, the company has an impressive pipeline of products in development and clinical trials across a range of therapeutic areas.
The Associate Director of Product Development will take ownership of the successful delivery of Dose Delivery Medical Device product development projects and programmes through performing the following duties:
- Overall responsibility for all product development projects in the portfolio including overall development strategy.
- Manage, lead and motivate matrix CMC project teams, both internal and with external partners.
- Plan, coordinate and supervise complex projects or programmes with regard to budget, time-lines and resources, interface planning and project documentation of pharmaceutical development tasks.
- Monitor/supervise the manufacturing of drug products, drug substances or medical devices with contractors.
- Prepare and manage subsequent maintenance of pharmaceutical information regarding development, manufacturing and analytical testing of drug substances, drug products or medical devices for regulatory documentation for global submissions.
- Manage the transfer of pharmaceutical manufacturing processes from lab scale to production scale and process validation.
- Develop the formulation platform-strategies for development projects.
Please note, this role will initially be stand-alone although it is anticipated it could grow into a line management position as the program expands.
A competitive salary commensurate with experience, bench-marked at up to £80,000, is available with flexibility on either side if this figure. This is complemented by a comprehensive flexible benefits package that can be configured to suit individual needs and includes a car leasing option.
Educated to at least degree level we are seeking a minimum of 10 years’ experience in the Pharmaceutical and/or Medical Devices sector leading or managing complex early and late stage development programmes for a portfolio of products. You will be able to demonstrate strong project and people management skills including leading multifunctional teams while utilising project management tools and processes. Your experience can be either pharmaceutical and/or medical devices as we are seeking broad expertise across the product development function. Other expertise will include implementing Quality by Design Principles, pharmaceutical regulations (GxP) and international guidelines.
Keywords Product Development Manager, Senior Product Development Manager, Lead Product Development Manager, Product Development Director, Associate Director Product Development, Product Development AD, Lead Product Development Manager, Pharmaceutical, Biopharmaceuticals, Medical Devices, CMC, Chemistry, Manufacturing and Controls, Quality by Design Principles, GxP, GMP
This is a permanent position.