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Senior Product Development Manager - United Kingdom  

Mundipharma Research (company)

Posted on : 21 August 2017

Project Description

Job Introduction



Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

  • 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.

Key Competencies

  • 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

Main requirements

  • 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. 

Contact Information

Name: Vanessa McHaffie
Telephone: 01223 400400
Adress: Mundipharma Research Limited
Unit 196
Cambridge Science Park
Milton Road