CMC Manager

Are you passionate about making a difference in the lives of patients with rare diseases? Join our dynamic team at TFS HealthScience as we expand our horizons and contribute to groundbreaking advancements in healthcare.

Sponsored-based in Sweden, with remote work options available. 

About Us:

TFS HealthScience is a leading mid-sized Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. With a focus on excellence and innovation, we strive to deliver high-quality solutions that make a difference in patients' lives.

About the Opportunity:

As CMC Manager, you'll play a crucial role in driving the development of life-changing treatments for rare oncology diseases. You'll provide strategic guidance and support in CMC regulatory affairs, ensuring the successful development and commercialization of drug candidates.

Key Responsibilities:

• Lead CMC regulatory guidance and support for drug development projects, ensuring adherence to rigorous standards.
• Collaborate with cross-functional teams to integrate CMC considerations into product development plans.
• Participate in regulatory project teams to facilitate high-quality submissions to Regulatory Authorities.
• Maintain and expand scientific networks within the oncology space, fostering relationships with key stakeholders.
• Prioritize patient safety throughout the drug development process.

Qualifications:

• Bachelor's or Master's degree in a relevant field (e.g., chemical engineering).
• Experience in CMC within the pharmaceutical industry, preferably with a focus on oncology.
• Proven track record in preparing regulatory documents and managing drug substance and drug product activities.
• Experience with Contract (Development) Manufacturing Organizations.
• Strong knowledge of cGMP and quality product risk assessment.
• Ability to work independently and translate company goals into CMC deliverables.
•  Excellent communication skills in English

Why choose TFS:

• Join a dynamic and collaborative team dedicated to advancing healthcare and improving patient outcomes.
• Opportunities for professional growth and development within a leading Contract Research Organization.
• Work in a supportive environment that values innovation, integrity, and excellence.
• Make a difference with us at TFS HealthScience! Apply now to be part of our mission to drive innovation in clinical development and transform patient care.