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Senior Director CMC Operational Excellence
ProQR's CMC department is currently looking for a Senior Director CMC Operational Excellence (full-time) to join our team.
Het bedrijf / The company
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 140 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.
The CMC Department
The Chemistry, Manufacturing and Control (CMC) Department has a central role within the ProQR Therapeutics organization. The CMC Department develops, manufactures and characterizes oligonucleotides and therapeutic formulations for clinical development and commercialization. We have many programs in early stage development and one in late stage development. Our way of working involves a combined approach of in house and outsourced activities.
De functie / The role
Currently, we are looking for a seasoned operational professional to structure the CMC department for late stage development and commercialization. We are looking for a hands-on professional that has brought products to the stage of NDA and beyond that, with a background in operational excellence, drug development and high affinity for structure and digitalization.
The candidate will not be directly involved in the development projects but will be working on the long term structure of the department.
The Sr. Director CMC Operational Excellence will report to the Head of CMC and will support the CMC functional leaders (AD/QC, CMC Program Management, Process Dev, Formulation Dev, Manufacturing, Clinical Supplies) with departmental organization, systems, implementation of tools, metrics and business processes to accommodate ongoing development projects together with further expansion of the department and capabilities. While functionally aligned in CMC, the Sr. Director CMC Operational Excellence will collaborate closely with internal stakeholders such as Quality, Regulatory Affairs, Finance, Legal, Commercial and IT to facilitate cross-functional CMC related business continuation and improvement aligned with ProQR values and objectives.
Projects could involve for example inventory management, URS definition & implementation, design of tool for criticality assessments.
Location: Leiden, NL (preferred) or Cambridge, Massachusetts, US
Het profiel / Your profile
We expect our Sr Director CMC Operational Excellence to have:
o an advanced degree (PhD/MSc/Engineer; or appropriate Master"s level) preferably in (Bio)Chemistry, Pharmaceutical Sciences or Life Sciences
o at least 10-15 years of working experience within the Biotech / Pharmaceutical industry
o proven track record in late stage development manufacturing, process validation and product launch
o knowledge of CMC guidelines applicable in Europe and USA
o proven track record in Operational Excellence and design and implementation of (cross-functional) business tools and processes
o skilled in business process mapping & lean six sigma
o understanding of complexity and volume of CMC data in order to identify relevant solutions for digitalization.
o affinity with business analytics, KPIs & visualization solutions
o experience in commercial distribution and inventory management is a pre.
o experience in or affinity with the field of (ultra)orphan products is a pre.
Skills and competencies that are required for making the difference:
o Analytical and accurate, well-organized
o Long term thinker
o Flexible and able to deal with change
o Hands-on mentality
o Pro-active attitude
o Autonomous and coachable
o Being able to work in a fast pace environment, having strong project planning and management skills, being able to prioritize multiple tasks
o Critical thinking, decision making and problem solving skills
o Excellent communication skills
o Excellent knowledge of spoken and written English
o A nice person :-)
Het aanbod / The offer
We offer an exciting and innovative working environment in a very committed organization, with competitive benefits, including an annual performance bonus, stock options, flexible working arrangements and unlimited (un)healthy snacks and drinks. The salary and terms of employment will be discussed in detail at an appropriate stage of company interview.
In hiring new ProQRians, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Do you want to be part of our devoted team of enthusiastic professionals? If so, we"re looking forward to receiving your application by filling out our application form.
Reactie / Reaction
Please apply as soon as possible if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.