vp cmc

Job Description

Vice President of Chemistry, Manufacturing, and Controls - Remote (EU based)

Company Overview:

Join our innovative and dynamic startup at the forefront of antibody therapeutics. We are a rapidly growing biotechnology company dedicated to advancing groundbreaking treatments that address unmet medical needs. Our team is driven by a passion for scientific excellence and a commitment to transforming the landscape of healthcare. If you're ready to contribute significantly to the field of antibody therapeutics, we invite you to join us.

Job Type: Full-time

About the Role:

As the Vice President of CMC, you will play a crucial role in leading our Chemistry, Manufacturing, and Controls efforts. You will be responsible for developing and implementing CMC strategies to ensure the successful progression of our antibody therapeutic candidates from early development through commercialization. This role offers a unique opportunity to contribute to the growth and success of a startup while collaborating with a highly motivated and talented team in a remote setting.

Key Responsibilities:

• Lead and oversee all aspects of CMC activities, including process development, manufacturing, and quality control, for antibody therapeutic candidates.
• Collaborate with cross-functional teams to design and implement CMC strategies aligned with regulatory requirements and industry best practices.
• Establish and manage relationships with external CMOs (Contract Manufacturing Organizations) and other key partners to ensure successful and efficient manufacturing operations.
• Provide technical leadership and guidance to internal teams and external partners on CMC-related issues.
• Contribute to the development and execution of regulatory submissions and interact with regulatory agencies as needed.

Qualifications:

• Ph.D. in a relevant scientific discipline with a minimum of 10 years of experience in biopharmaceutical CMC, including antibody therapeutics.
• Proven track record of successfully leading CMC activities from preclinical development through commercialization.
• Experience in working with external CMOs and managing CMC-related outsourcing activities.
• Strong knowledge of regulatory requirements for biologics and experience in regulatory interactions.
• Excellent leadership, communication, and collaboration skills.
• Ability to work independently and thrive in a fast-paced startup environment.