CMC Project Manager
CMC Project Manager - Senior Consultant
National assignments, headquarters Hoofddorp - 32/38 hours
As a CMC Project Manager / Senior Consultant at Progress-PME, you can expect to be deployed in various capacities. You will lead CMC projects and provide expertise and advice in the field of development, upscaling, validation and/or registration of small molecules, biologicals or ATMPs to the customer. You have long-standing experience with CMC projects in the (bio)pharmaceutical industry in the role of project manager and/or subject matter expert in, for example, process development or analytical development. In this role, you will act as an intermediary between the client, stakeholders, project team members and third parties. You can lead a CMC (sub) team aimed at developing new or improved products during early or late (bio)pharmaceutical development. As a CMC Project Manager, you will be responsible for planning, quality and budget control of all required CMC activities ranging from process development and analytical development studies and preparation of material for non-clinical and clinical studies up to and including the delivery of all necessary CMC documentation for submission and approval of a registration file.
- a University or Higher Professional Education (HBO) degree in biotechnology, chemical technology, biochemistry, pharmacy or similar;
- 7-10 years of relevant work experience in the (bio)pharmaceutical industry, at different companies;
- 5-10 years of relevant work experience in CMC development of small molecules, biologicals or ATMP products, including experience with Quality by Design and/or knowledge of qualification and validation of analytical methods;
- extensive knowledge of and experience with upscaling and (bio)pharmaceutical production;
- proven CMC project management experience and knowledge of and experience with project management tools (Prince2 or similar);
- experience in drafting project plans, study plans, validation documents and (financial) reports;
- experience in working with external parties to supply materials or conduct studies;
- extensive knowledge of pharmaceutical production and familiarity with cGMP requirements and other relevant regulations and guidelines;
- knowledge of statistics and process control systems is an advantage;
- affinity with registration processes for new or modified products within the EU and/or the US is an advantage;
- effective communication skills;
- high proficiency in Dutch and English.
- pro-active, pragmatic, flexible and customer-oriented;
- accustomed to balancing business and/or operational targets and delivering high-quality work;
- accustomed to working in a dynamic organisation;
- thorough and systematic approach;
- capable of advising, persuading, and motivating others;
- accustomed to communicating at both management and operational level;
- willing to take ownership;
- team player.
- a healthy growing company with an informal work environment and focus on human capital;
- a varied job in challenging projects at renowned companies in the life sciences & healthcare industry;
- opportunities for professional development, both in practice and through courses, trainings and networking events;
- short communication lines, personal commitment, team spirit;
- an exciting and learning environment;
- a healthy work-life balance;
- a competitive salary and benefits;
- a company car.