Associate Director of Product Development - United Kingdom
- Manage, lead and motivate matrix CMC project teams, both internal and with external Partners. You are responsible for a range of projects in our portfolio.
- Plan, coordinate and supervise complex projects or programmes with regard to budget, timelines 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.
As Soon As Possible
- Ability to confidently lead multifunctional teams (both internally and with external partners) understanding the input into project decisions
- Ability to work independently take initiative and complete tasks to timelines
- Strong strategic thinking
- Acts as a mentor for your team and to other colleagues
- Assertiveness, influencing and negotiating skills
- Ability to effectively present information to management, external contractors and employees at all levels of the organization.
- 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 10 years’ experience in pharmaceutical industry .Proven experience of leading/managing complex early and late stage drug product and device developments programmes.
- Strong experience in the Device Development would be required.
- Experience of implementing Quality by Design Principles, Strong networks to scientific research organisations, universities and associations.
- Strong project and people management skills and excellent communication skills.
- In-depth knowledge in project management tools and processes.
- In-depth knowledge and understanding on pharmaceutical laws and regulations (current GMP regulations).
- Very good knowledge on international Guidelines Customer focused, thrives on challenge.
|Adress:||Mundipharma Research Limited |
Cambridge Science Park