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.

Sponsoredbased in Sweden with remote work options available.

About Us:

TFS HealthScience is a leading midsized 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 highquality solutions that make a difference in patients lives.

About the Opportunity:

As CMC Manager youll play a crucial role in driving the development of lifechanging treatments for rare oncology diseases. Youll 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 crossfunctional teams to integrate CMC considerations into product development plans.
• Participate in regulatory project teams to facilitate highquality 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:

• Bachelors or Masters 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.