*REMOTE* - Program Manager CMC

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Overview:

We are seeking an experienced and highly motivated CMC (Chemistry, Manufacturing, and Controls) Program Manager to join our team. The ideal candidate will have extensive commercial experience, proven expertise in managing relationships with Contract Development and Manufacturing Organizations (CDMOs), and a strong background in MSAT (Manufacturing Science and Technology), or process development, and protein products from clinical stages to post-commercialization. This role demands a strategic thinker who can manage complex projects, engage with key stakeholders, and act as the primary point of contact for CDMOs/CMOs/CROs.

Key Responsibilities:

• Lead and manage CMC programs, ensuring alignment with commercial goals and regulatory requirements.
• Develop and execute program plans, timelines, and budgets.
• Monitor and report program progress, identifying and mitigating risks proactively.
• Serve as the single point of contact for CDMOs, managing all aspects of the vendor relationship.
• Negotiate contracts and oversee CDMO performance to ensure compliance with quality and regulatory standards.
• Have early career subject matter expertise in a relevant field I.e. MSAT, Process development, or equivalent. Experience with protein-based products is preferred.
• Collaborate with MSAT, Analytical, drug product, drug substance, supply chain, and quality teams to ensure seamless integration of CMC activities.
• Utilize early career floor work experience to inform practical and effective program strategies.
• Engage with internal and external stakeholders, facilitating effective communication and collaboration.
• Identify and leverage the right experts for specific technical challenges.

Qualifications/Experience

• Ph.D. in Chemical Engineering or a related field is preferred but not required.
• Minimum of 10 years of industry experience.
• Demonstrated success in managing commercial operations and programs involving protein products from clinical development through post-commercialization.
• Proven experience in interacting with CDMOs and managing vendor relationships.
• Hands-on experience with floor work in early career stages is highly desirable.

Skills

• Strong project management and organizational skills.
• Excellent communication and negotiation abilities.
• In-depth knowledge of regulatory requirements and quality standards in the biopharmaceutical industry.
• Ability to think strategically and execute tactically.
• Problem-solving: Strong analytical skills and ability to navigate complex challenges.
• Flexibility to manage changing priorities and demands in a fast-paced environment.
• Proven ability to work effectively with diverse teams and stakeholders.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.