Dir. of External Manufacturing, CMC

Job Title: Dir. of External Manufacturing, CMC

Job Number: 90359

Location: , US

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.

Application Deadline: 2025-02-03