Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!

Proclinical is recruiting for a Drug Product Project Leader to strategically lead complex drug product development projects, particularly in biologics. In this role, you will oversee cross-functional teams, ensure high-quality deliverables for CMC submissions, and contribute to the advancement of innovative drug product strategies. This position involves collaboration with multidisciplinary teams and offers opportunities to represent the organization externally through industry engagements.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Lead and coordinate global drug product sub-teams, including experts from formulation, process development, analytics, production, devices, and regulatory functions.
• Represent Drug Product Development on the global CMC team and ensure adherence to scientific and project review processes.
• Create and review high-quality drug product development documents to support strong CMC submission packages.
• Author or review regulatory CMC documents, address drug product-related questions during inspections, and support health authority requests.
• Plan and manage resources and budgets for drug product development activities, both internally and externally.
• Communicate project strategies, adapt priorities as needed, and ensure alignment with organizational goals.
• Lead key scientific initiatives to develop short- and long-term drug product development strategies for a robust biologics pipeline.
• Provide guidance and mentorship to junior scientists and project leaders, fostering scientific and project management excellence.
• Present scientific-technical results internally and represent the organization externally at meetings, conferences, and industry consortiums.

Key Skills and Requirements:

• Advanced degree (e.g., PhD) in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or a related field.
• Expertise in biologics drug product formulation, process development, manufacturing scale-up, and technology transfer.
• Knowledge of protein analytics, lyophilization, and primary packaging development for biologics is advantageous.
• Experience with regulatory submissions (e.g., BLA, MAA) and addressing health authority inquiries.
• Proven ability to resolve technical challenges and lead strategic innovation projects.
• Strong interdisciplinary thinking, project management skills, and experience working in cross-functional international teams.
• Excellent communication, negotiation, presentation, and scientific writing skills.
  

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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