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Senior Product Development Manager Cambridge United Kingdom,
Mundipharma Research (company)
Posted on : 21 August 2017
As Soon As Possible
- Manage, lead and motivate matrix CMC project teams mainly in the novel biopharmaceutical and Biosimilars arena, both with internal and with external partners.
- Plan, coordinate and supervise complex projects or programmes with regard to budget, timelines and resources, interface planning and project documentation of biopharmaceutical development tasks.
- Monitor/supervise the outsourced external biomanufacturing of drug products, drug substances or medical devices and their respective stability studies with contractors.
- Prepare and manage subsequent maintenance of biopharmaceutical information regarding lab/pilot development, commercial scale manufacturing and analytical testing of drug substances, drug products or medical devices for regulatory documentation for global submissions.
- Manage the transfer of biopharmaceutical manufacturing processes from lab scale to production scale and process validation.
- Develop the formulation and device-combination (if required) platform-strategies for development projects.
- Contribute to Due Diligence activities and assessments of third party manufacturing sites.
- Ability to lead multifunctional teams (both internally and with external partners) understanding the input and analysis of critical paths into project decisions.
- Ability to work with minimal guidance, take initiative and complete tasks to timelines with occasional peer review.
- Good strategic thinking.
- Acts as a subject matter expert to other colleagues.
- Assertiveness, excellent influencing and negotiating skills.
- Ability to effectively present information to management, external contractors and employees at all levels of the organisation.
- Ability to assess complex programs from a risk management and contingency planning perspective management and contingency planning perspective
- Successful completion of academic degree or PhD in Pharmacy (or related field) or demonstration of equivalent experience and expertise.
- Minimum 5 years experience in biopharmaceutical industry.
- Proven experience of leading/managing complex early and late stage Biopharmaceutical development programmes.
- Strong experience in multidisciplinary aspects of biopharmaceuticals would be required.
- Experience of implementing Quality by Design Principles, Ability to build networks with scientific research organisations, Universities and other associations.
- Strong project management skills and communication skills
- In-depth knowledge of project management tools and processes.
- In-depth knowledge and understanding on pharmaceutical laws and regulations (current GxP regulations).
- Very good knowledge on international Guidelines, Customer focused, thrives on challenge.
|Adress:||Mundipharma Research Limited |
Cambridge Science Park
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