Director Biologics Drug Substance

The organization

For a leading and promising late clinical-stage biotech company in the area of Utrecht, we are currently looking for a Director Biologics Drug Substance. In 2018, the company successfully completed a Phase IIb trial. Now the focus is on preparing to launch the Phase III / registration trial. The company is gearing up to build the organisation that will deliver on the next phase of evolution. The new organisation has involved several new key positions with large pharma/biotech Phase III experience. The focus will be on operational excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorization submission package. The size of the organisation will allow for expanding the pipeline and/or accommodating new strategic opportunities.

The position

The Director Biologics Drug Substance will be responsible for coordinating late-stage drug development and initiating the drug administration process with a strong emphasis on quality and time. You closely work with the CMOs in the area of ??process characterisation and validation, production planning, and forecasting programs. In this role you are responsible for reviewing late-stage research proposals, proactively contribute to risk assessments and control strategies, review and approve batch registrations, and supporting regulatory documentation. Next to this, you will coordinate with internal and external professionals in CMC, clinical operations, regulatory affairs, quality assurance, and commercial.

Furthermore, you act as a drug and herbal specialist, monitoring and supporting the development and manufacturing strategy for clinical trials and commercial launches. By maintaining close communication with all stakeholders you ensure excellent support for regulatory submissions and adequate drug delivery throughout the clinical trials and commercial launches. You are also responsible for performing regular alignment of production strategy, bringing issues to the attention of the team, updating production and distribution plans accordingly, and adhering to all GMP regulations to ensure full compliance.

Candidate profile

We are looking for a candidate that fits the following requirements:

• Master/PhD degree, preferably in biology or a related field
• Strong knowledge of both upstream (USP) and downstream and analytical development of novel biologics
• At least ten years of experience in late-stage development
• Experience acquired in a GMP/FDA regulated pharmaceutical company, preferably supporting Phase-III programs and launch
• Experience with managing CMO
• Confident with coordinating BLA’s and MAA’s and process scale-ups
• Strong interpersonal skills: you are pro-active and stress resistant. In addition, you have a hands-on, pragmatic, and solution-oriented attitude
• Well-developed organisational and communication skills. You are able to express yourself well in English, any other European language is considered a plus

The offer

The company can offer you a base salary between € 90.000 and € 110.000 annually based on a full-time workweek (40hr). In addition, in this organisation people work together in a constructive, collaborative, and team-oriented way, towards achieving the company objectives without losing sight of their own objectives.

Interested?

If you are interested in this job, you can apply by using the link below. For more information please contact Aron Berhane, Senior Associate | Biotech & Pharma, +31(0)6-30306982.