CMC lead at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our CMC department is currently looking for a CMC lead (Director Level, full-time) to join our team.
The CMC department has a central role within the ProQR Therapeutics organization. The CMC Department develops, manufactures and characterizes oligonucleotides and therapeutic formulations for research, clinical development and commercialization. The CMC Lead reports to the VP CMC and as member of the clinical project teams, organizes all activities executed by the CMC teams to support clinical development.
Location: Leiden (The Netherlands)
We expect our CMC lead to have:
• an advanced degree (PhD) with 3-5 years of relevant experience, or appropriate Master’s level degree with 5-8 years of relevant experience preferably within the Biotech / Pharmaceutical industry performing progressively advanced duties
• an established CMC reputation through CMC accomplishments directed towards pharmaceutical development programs
• experience working in small biotech/start-up and/or rare diseases is an advantage
• experience in leading and managing teams and managing multiple projects concurrently
• thorough knowledge of compliance rules and CMC processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP)
• Oversees CMC related project activities for the company’s RNA products from early-stage development through regulatory filings
• Represents the CMC function in Project Teams
• Actively manages all CMC aspects of regulatory submissions (IND, IMPD, etc.) and interactions for relevant products in close collaboration with Regulatory, Program Management and other involved departments. Provides input into the financial performance and/or efficiency and effectiveness of the CMC project teams of the development programs to oversee and enable the CMC deliverables
• Support the CMC aspects of the clinical-stage programs, such as in LCA10 and Usher Syndrome, and help support to bring forward other pipeline programs
• Directs the execution of multiple CMC projects based on results
• Plays a significant role in defining key elements and timelines for achieving CMC product strategies
• Translates and implements the communication strategy across work groups
• Strong organizational and time/project management skills including the ability to function effectively in a team environment
• Pro-active attitude
• Proven experience in managing teams, budgets and resources
• Outstanding planning, communication and collaboration skills including leading teams with cross-functional scope
• Excellent demonstrated interpersonal, verbal and written communication skills and the ability to influence without authority. Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a “hands-on” fashion
• Demonstrated experience within the biotech/pharma industry in CMC
• Excellent knowledge of spoken and written English (and Dutch)
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
• A competitive salary
• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible but before 5 February 2020 if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.
Please note that a screening is part of our selection procedure.