VP Head of CMCApply for VP Head of CMC . Opens in new window.
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 35 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.
We are currently looking for an experienced VP, Head of Chemistry, Manufacturing & Control (full-time) to join our team.
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.
We are looking for an experienced professional in Chemistry, Manufacturing & Control to lead the CMC department. The Head of CMC has brought products to the marketing stage and beyond that, with a diverse background in CMC, drug development, commercialization, and supply chain. In addition, the Head of CMC has a strong background in people management and brings a network in the CMC space.
The Head of CMC is ultimately accountable for the on-time delivery of investigational product supplies and future commercial product. In addition, the head of CMC is accountable for the CMC content of the regulatory dossier and subsequent authority interactions. The span of control of the Head of CMC is ranging from pre-clinical, Phase I, Phase II/ Phase III through commercial launch, including clinical trial and commercial supply chain.
The candidate will lead a department of initially 20-25 employees covering AD/QC, CMC Program Management, Process Chemistry, Formulation Development, Manufacturing and Clinical Supplies Management and Logistics and is accountable for in house laboratories, vendor network and other external relationships.
The Head of CMC will be reporting to the COO and is part of the company's leadership team.
Tasks and key duties
- Responsible for developing and executing the Chemistry, Manufacturing & Control strategy
- Responsible for the financial performance of the CMC department
- Provide support to the development and realization of corporate goals and e.g. contribute to making scientific / technical decisions on the acquisition of new products / projects
- Responsible to oversee and enable activities to ensure efficiency and effectiveness of the CMC department and ProQR as a whole
- Identify and analyse high-impact, complex and cross-functional business issues and gaps. Make sure continuous improvement of processes is embedded in the organization. Embed an environment of innovation and cultivate new (scientific) insights
- Responsible for hiring, promotions, pay adjustments, performance appraisals. Recruting and develop high performance team. Develop individual team members’ hard and soft skills (challenge, motivate, reward), using individual development plans. Drive development of intellectual capital and continuous education and capability building. Act as a mentor for teams and individuals
- Responsible to act across disciplines with senior leaders and external parties to drive and align strategic and operational activities. Responsible for alignment of functional execution plans with approved corporate plans.
- Continuously monitor progress, costs, resource allocations, timelines and develop corrective actions if deviations occur
- Communicate effectively across work groups, departments and with MT.
We expect our Head of CMC to be/have
- Independent thinker with demonstrated ability to take the lead
- A deliverable oriented mindset, wit strong sense of ownership
- An advanced degree in biochemical engineering, pharmaceutical chemistry, biochemistry, or relevant technical discipline, coupled with 15+ years relevant pharma and/or biotech experience
- Experience in late stage manufacturing, process validation and clinical and commercial supply chain management
- Proven track record in cGMP manufacturing and IND, CTA and NDA/MAA filings; thorough knowledge of relevant FDA and EMEA regulations
- Experience in working with oligonucleotides is a bonus
- Experience in working with orphan products
- Experience in overseeing outsourced manufacturing models and evaluating make versus buy concepts
- Track record in building working processes and organizational structure in a biotech environment
- Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations.
- Demonstrated ability to mentor and develop strong leaders.
- Able to work, adjust and lead in a fast-paced, highly dynamic environment.
- Demonstrated ability for innovative and big picture thinking.
Skills and competencies that are required for making the difference
- Lead by example
- Flexible and resistant to change
- Critical thinking, decision making and problem-solving skills
- Analytical and accurate
- Being able to work in a fast pace environment
- Strong line management skills
- Being able to prioritize multiple tasks
- Excellent communication skills
- Pro-active and pragmatic self-starter, with a result-oriented mindset
- A nice person :-)
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
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 are looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position. You can contact Femke Hekelaar via email@example.com if you have any questions.