CMC Manager

CMC Manager – Czechia – Biotech

Global Life Science Hub are seeking an experienced CMC Manager to join our growing clinical-stage biotech client developing novel immunotherapies. The company’s pipeline includes a range of innovative therapies, including cellular therapies, monoclonal antibodies, and small molecules.

As the CMC Manager, you will be responsible for overseeing all aspects of Chemistry, Manufacturing, and Controls (CMC) for their portfolio of biologics products, from development through commercialisation.

Responsibilities:

• Develop and implement CMC strategies to ensure timely and successful development, manufacturing, and launch of our biologics products.
• Manage all CMC-related activities with external partners, including contract manufacturing organizations (CMOs) and contract research organizations (CROs).
• Collaborate with internal teams, including Research & Development, Quality Assurance, Regulatory Affairs, and Clinical Development, to ensure successful execution of CMC strategies.
• Monitor and manage project timelines, budgets, and risks associated with CMC activities.
• Prepare and review CMC sections of regulatory submissions, including INDs, BLAs, and other regulatory filings.
• Ensure compliance with regulatory requirements and industry best practices.

Experience/Qualifications:

• Bachelor’s or Master’s degree in a scientific discipline (e.g., chemistry, biochemistry, biotechnology, or related field).
• At least 5 years of experience in CMC-related roles within the biotech or pharmaceutical industry.
• Proven track record of successful CMC project management and product launches.
• Strong understanding of regulatory requirements related to CMC, including ICH guidelines and FDA and EMA regulations.
• Excellent communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.
• Experience with biologics, particularly cell and gene therapies, is preferred.

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com

GLS Hub