Position Overview

We are seeking an experienced CMC Consultant to join our team in advancing innovative therapeutics from concept to clinic. This role will be critical in executing Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. The ideal candidate will be a senior CMC expert who excels in both advisory and execution roles, working closely with our lean internal team and external Contract Development and Manufacturing Organizations (CDMOs).

Key Responsibilities

• Define and execute the overall CMC development strategy to support clinical progression and trial readiness.
• Guide CMC development efforts for our lead asset, ensuring alignment with regulatory requirements.
• Manage external partnerships with CDMOs to ensure the timely and efficient delivery of drug products.
• Provide tactical oversight across drug product development, including formulation and analytical strategy.
• Facilitate integration with our device-enabled delivery system to enhance therapeutic outcomes.
• Support the preparation of regulatory submissions and ensure compliance with industry standards.

Requirements

• Advanced degree in a relevant scientific discipline (PhD, MS, or equivalent).
• Minimum of 7 years of experience in CMC, specifically within the pharmaceutical or biotechnology sector.
• Proven track record in guiding drug development through the NDA pathway.
• Strong knowledge of regulatory requirements and CMC best practices.
• Exceptional communication and interpersonal skills to work effectively with internal and external stakeholders.
• Ability to thrive in a fast-paced, dynamic environment while managing multiple priorities.

Benefits

• Competitive compensation based on experience and qualifications.
• Flexible working hours and the opportunity for remote work.
• Collaborative and innovative work environment.
• Opportunity to contribute to meaningful advancements in healthcare.
• Professional development opportunities to enhance your skills and career.