TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

The Drug Substance Outsourcing Manager is responsible for leading and coordinating the outsourcing of drug substance development and manufacturing activities. This critical role ensures optimal supplier relationships and alignment with operational and strategic goals, contributing directly to our mission of improving patient access to life-changing treatments.

As part of our SRS Nordics division, you will collaborate closely with a global pharmaceutical/biotech sponsor dedicated to advancing innovation in biologics development.

Key Responsibilities:

• Outsourcing Management: Lead and coordinate drug substance outsourcing activities, including vendor identification, evaluation, and selection.
• Vendor Relationships: Build and maintain strong relationships with Contract Development and Manufacturing Organizations (CDMOs) to ensure efficiency, quality, and compliance.
• Project Oversight: Manage outsourced projects, ensuring deliverables are met on time, within budget, and according to quality standards.
• Contract Negotiations: Negotiate contracts and budgets to ensure cost-effective and high-quality outcomes.
• Compliance: Ensure adherence to regulatory requirements, Good Manufacturing Practices (GMP), and company policies.
• Collaboration: Partner with internal teams such as R&D, Quality Assurance, and Regulatory Affairs to align on project goals and timelines.

Qualifications:

• Education: A degree in life sciences, biotechnology, or a related field (advanced degree preferred).
• Experience:
  • Minimum of 5 years of experience in drug substance manufacturing and outsourcing.
  • Proven experience managing CDMO partnerships in the biotechnology or pharmaceutical industry.
• Knowledge:
  • In-depth understanding of biologics manufacturing processes, GMP requirements, and global regulatory frameworks, especially in the Nordics.
• Skills:
  • Strong project management and organizational skills.
  • Excellent negotiation and communication abilities.
  • Ability to work cross-functionally and build strong relationships with internal and external stakeholders.
• Language Proficiency: Fluency in English is required; knowledge of Swedish is a plus.

What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light, serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.