Drug Substance Outsourcing Manager

TFS HealthScience

Stockholm, Sweden

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.