Employment Type: Consultant

Job Category: Biotechnology

Department: Technical Operations / Manufacturing Strategy

Reports To: To be determined

Job Number: 3500351

Role Overview

We are seeking an experienced executive advisor to support late-stage development and commercialization readiness for a biotechnology program. This role will provide strategic and technical guidance across manufacturing, process validation, and regulatory preparation to ensure a successful transition from clinical to commercial operations.

Key Responsibilities

• Advise on pre-BLA and PPQ readiness activities.
• Support manufacturing scale-up, tech transfer, and MSAT initiatives.
• Collaborate with internal teams to develop commercialization strategies and ensure compliance with regulatory standards.
• Provide expertise in late-phase clinical operations and commercial launch planning.

Qualifications

• Proven experience in biopharma or biotech commercialization, ideally with multiple products taken through BLA/MAA submissions.
• Strong background in manufacturing sciences, process validation, and quality systems.
• Ability to work in a consultative capacity, offering flexible engagement models (remote, hybrid, or on-site).
• Excellent communication and stakeholder management skills.