Dir. of External Manufacturing, CMC

Job Title: Dir. of External Manufacturing, CMC

Job Number: 35727

Location: , 

Job Description

We are looking for an experienced Director of External Manufacturing to lead and manage external operations for peptide conjugates, ensuring on-time delivery, quality compliance, and cost efficiency. This role involves close collaboration with internal teams and external partners to align with organizational goals.

Responsibilities

• Develop and manage strategies for selecting, negotiating, and overseeing CMOs to meet company goals.
• Build and maintain strong CMO partnerships to ensure effective communication and long-term collaboration.
• Oversee CMO performance, production planning, and issue resolution.
• Support technology transfer and scale-up for new products.
• Ensure timely product delivery with high-quality standards and regulatory compliance.
• Collaborate with Quality Assurance to ensure CMO adherence to GMP and regulatory guidelines.
• Address operational challenges, deviations, and supply disruptions.
• Monitor budgets and implement cost-effective manufacturing solutions.
• Coordinate with internal teams to align manufacturing activities.
• Stay informed on industry trends, technologies, and regulations to promote continuous improvement.

Required Skills

• Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 8+ years in pharmaceutical manufacturing, including 5+ years managing CMOs.
• Expertise in manufacturing, testing, and controls for solid-phase peptide production.
• Experience in peptide and protein manufacturing.
• Strong knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA).
• Proven success in tech transfers, scale-up, and commercial manufacturing.
• Excellent project management and problem-solving skills.
• Effective interpersonal and communication skills for collaboration with stakeholders.
• Agile, adaptable, and able to navigate ambiguity.
• Commitment to transparent communication and fostering respectful, open dialogue.
• Driven to contribute to a mission-oriented organization focused on patient impact.