Based in Cambridge, this is a new Senior Product Development Manager position with a medium sized, globally based, pharmaceutical group. The role focuses on the planning, coordination and execution of complex Biopharmaceutical and Biosimilar development projects or programmes covering the entire CMC lifecycle including matrix project team leadership, budget management, timeline accountability and results delivery.
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 Senior Product Development Manager will take ownership of the successful deliver of Biopharmaceutical and Biosimilar product development projects and programmes through performing the following duties:
- Managing, leading and motivating matrix CMC project teams mainly in the novel Biopharmaceutical and Biosimilars arena with both internal and with external partners.
- Planning, coordinating and supervising complex projects or programmes including budgets, timelines and resources, interface planning and project documentation of development tasks.
- Monitoring and overseeing the outsourced external biomanufacturing of drug products, drug substances or medical devices and their respective stability studies with contractors.
- Preparing and managing subsequent maintenance of biopharmaceutical information regarding laboratory/pilot development, commercial scale manufacturing and analytical testing of drug substances, drug products or medical devices for regulatory documentation for global submissions.
- Managing the transfer of biopharmaceutical manufacturing processes from laboratory scale to production scale and process validation.
- Develop the formulation and device-combination platform-strategies for applicable development projects.
- Contribute to Due Diligence activities and assessments of third party manufacturing sites.
A competitive salary commensurate with experience, benchmarked at up to £45,000, 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 5 years’ experience in the Biopharmaceutical sector leading or managing complex early and late stage development projects / programmes. You will be able to lead multifunctional teams while utilising project management tools and processes in delivering project results. Specific expertise will include implementing Quality by Design Principles, understanding of pharmaceutical regulations (GxP) and international guidelines. Candidates are welcome from a range of multidisciplinary Biopharmaceutical development environments including pharmaceutical, biotech, CRO/service providers and academia.
Keywords Product Development Manager, Senior Product Development Manager, Lead Product Development Manager, Biopharmaceutical, Biosimilars, Biologic Medical Product, CMC, Chemistry, Manufacturing and Controls, Quality by Design Principles, GxP, GMP
This is a permanent position.