Freelance CMC Specialist – Small Molecules

About this Role

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.

We are currently seeking a Freelance CMC Professional Small Molecules to support one of our pharmaceutical partners in advancing their small molecule development and manufacturing activities. This senior-level consulting role offers a flexible commitment of 1020 hours per week for approximately 3 months.

As part of our SRS/FSP team you will be dedicated to one of our partners an innovative company focused on the development and commercialization of small molecule and ADC programs.

Key Responsibilities

• Provide CMC expertise in small molecule and ADC-related projects focusing on drug substance synthesis and drug product manufacturing.
• Collaborate with internal teams and external Contract (Development) Manufacturing Organizations (C(D)MOs) to ensure alignment with project goals and regulatory standards.
• Support process development scale-up and technology transfer activities.
• Ensure compliance with cGMP and contribute to quality risk assessments and documentation.
• Translate project objectives into actionable CMC deliverables and drive them to completion within timelines.
• Act as a subject matter expert advising on strategy process improvements and regulatory readiness.

Qualifications

• MSc or BSc in Chemistry Chemical Engineering Pharmaceutical Sciences or related discipline.
• Minimum of 5 years experience in CMC within the pharmaceutical industry with a focus on small molecule drug substance and drug product activities.
• Hands-on experience with manufacturing synthesis and ideally ADC (Antibody-Drug Conjugate) processes.
• Proven experience working with C(D)MOs and external manufacturing partners.
• Solid knowledge of cGMP and regulatory expectations.
• Strong analytical planning and execution skills with the ability to work independently.
• Excellent communication skills in English; other Nordic languages are an advantage.
  

What We Offer

This is a freelance consulting assignment offering flexibility and the opportunity to contribute your expertise to a high-impact project. Youll collaborate with a passionate and cross-functional team dedicated to bringing innovative therapies to patients.

We provide a competitive consulting arrangement professional support through TFS HealthScience and the chance to expand your network across the pharmaceutical development landscape.

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 Trust Quality Passion Flexibility and Sustainability guide everything we do. They help us attract and retain exceptional talent and foster a culture of innovation collaboration and excellence. Together we make a difference.