BrightOwl Loader Loading

Senior Product Development Manager Cambridge United Kingdom,  

Mundipharma Research (company)


Posted on : 21 August 2017

Project Description

Job Introduction

.

Location

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
Email: MR.HR@mundipharma-rd.eu
Telephone: 01223 400400
Adress: Mundipharma Research Limited
Unit 196
Cambridge Science Park
Milton Road
CB4 0GW

Locations

Cambridge (UK)

Find a Job Find Candidates

Similar Jobs

More jobs from Mundipharma Research

Other jobs in United Kingdom

Other jobs in Cambridge

Other jobs from Mundipharma Research in Cambridge

Other similar job in Cambridge

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like