Principle Scientist Small Molecules

Job Title: Principal CMC Scientist - Small Molecules

Location: Netherlands (On-site)

Company:

Join a pioneering biotech startup based in the Netherlands, dedicated to revolutionizing the field of pharmaceuticals. Their innovative approach focuses on Small Molecules to address unmet medical needs across various therapeutic areas. As they continue to expand their portfolio, they are seeking a highly skilled Principal CMC Scientist to join our dynamic team.

Role Overview:

As a Principal CMC Scientist specializing in Small Molecules, you will play a pivotal role in advancing our drug development programs from preclinical stages through to commercialization. You will lead the CMC (Chemistry, Manufacturing, and Controls) strategy, ensuring the successful progression of our small molecule-based therapeutics. This role offers a unique opportunity to contribute to cutting-edge research and make a significant impact on patients' lives.

Key Responsibilities:

• Develop and implement CMC strategies for small molecule drug candidates, encompassing formulation development, process optimization, and analytical methods.
• Lead and oversee all aspects of CMC activities, including drug substance and drug product manufacturing, technology transfer, and regulatory submissions.
• Collaborate closely with cross-functional teams, including chemistry, pharmacology, and regulatory affairs, to drive integrated drug development efforts.
• Design and execute studies to evaluate the physicochemical properties, stability, and manufacturing feasibility of small molecule compounds.
• Provide technical expertise and guidance on CMC-related issues, troubleshooting challenges as they arise throughout the drug development lifecycle.
• Stay abreast of industry trends, regulatory requirements, and best practices in small molecule CMC development to ensure compliance and optimize processes.

Qualifications:

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with a minimum of 5 years of experience in pharmaceutical CMC development, preferably focusing on Small Molecules.
• Proven track record of successfully leading CMC programs for small molecule therapeutics from early-stage development through to commercialization.
• Strong expertise in formulation development, process optimization, and analytical techniques relevant to Small Molecules.
• Excellent understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) governing small molecule drug development.
• Demonstrated ability to effectively collaborate within cross-functional teams and drive projects forward in a fast-paced, entrepreneurial environment.
• Outstanding communication skills with the ability to articulate complex scientific concepts to diverse stakeholders.

Why Join:

Opportunity to work at the forefront of biotech innovation, contributing to the development of novel small molecule therapeutics.

Collaborative and dynamic work environment that fosters creativity, learning, and professional growth.

Competitive compensation package including salary, benefits, and equity options.

Located in the vibrant biotech hub of the Netherlands, offering a high quality of life and excellent work-life balance.