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.
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.