VP, Head of Chemistry, Manufacturing & Control

ProQR Therapeutics

Leiden, Netherlands

The role:

We are looking for an experienced professional in Chemistry, Manufacturing & Control to lead the CMC department. The Head of CMC has developed products from Discovery through to late phase clinical studies, with a diverse background in CMC, drug development 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. 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 ranges from pre-clinical, Phase I, Phase II/ Phase III.

The candidate will lead a department of approximately 30 employees covering Drug Substance, Drug Product, Analytical and Clinical Supplies Management and Logistics and is accountable for in-house laboratories, vendor network and other external relationships. In the current phase of the company, the VP CMC also has an enterprise accountability for Quality, the training and documentation are coordinated by a small internal team while the other Quality operations are outsourced.

The Head of CMC is part of the company's leadership team.

Tasks and key duties:

Accountable for developing and executing the Chemistry, Manufacturing & Control strategy for pipeline products.
Accountable for the budget and financial performance of the CMC department
As a member of the Leadership Team contribute to the development of corporate goals and take accountability for delivery.
Responsible for overseeing and enabling activities to ensure the efficiency and effectiveness of the CMC department and ProQR as a whole, utilizing data trending and risk management tools.
Identify and analyze 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. Recruiting and developing a 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 for acting 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, with a strong sense of ownership
An advanced degree in biochemical engineering, pharmaceutical chemistry, biochemistry, or relevant technical discipline, coupled with 15+ years of relevant pharma and/or biotech experience
Experience in development of early and late-stage manufacturing, process validation and clinical 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 sterile drug products and oligonucleotides is a bonus
Experience in developing products for rare diseases
Experience in overseeing outsourced manufacturing models
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.