Director, Manufacturing Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Create manufacturing and operational strategies for commercial and late-stage clinical assets in partnership with Regional Operations, Supply Chain, Program leadership, and Directors of CMC Programs.

• Ensure effective leadership, execution, and delivery of process development and improvements for contract and regulatory compliance as well as commercial viability.

• Guarantee that global production, supply chain, logistics, and distribution planning align with clinical and commercial development needs.

• Supervise subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging.

• Collaborate with contract manufacturers to ensure that quality, delivery, and costs are met or surpassed.

• Oversee the manufacturing, quality, and product development processes from mid-stage clinical through to commercial launch.

• Maintain, monitor, and enhance both internal and external CDMO strategies.

• Identify strategies for cost reduction, supply redundancy, and process enhancements within the CDMO network.

• Formulate short- and long-term manufacturing and capacity strategies that are aligned with marketing objectives.

• Address complex technical challenges for effective business resolutions.

• Assist with quality investigations and non-conformances using product expertise.

• Lead, develop, and manage the performance of the manufacturing engineering team.

• Act as the technical lead for business reviews with suppliers and contracting organizations.

• Oversee technical transfers and process validations at both internal and external CDMOs.

⛳️ Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, or a related field.

• Over 10 years of combined experience in late-stage clinical to commercial cGMP manufacturing, engineering, contract manufacturing, and/or quality.

• At least 3 years of prior management experience.

• Direct experience in sterile injectable filling and lyophilization of drug products/substances that support clinical and commercial products.

• Experience with international contract manufacturing organizations.

• Willingness to travel approximately 30% of the time, both domestically and internationally.

• Preferred direct experience in secondary packaging of parenteral drugs.

• Preferred direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing.

• A strong commitment to excellence, results orientation, creativity, innovation, effective communication, collaboration, resilience, inclusivity, adaptability, ethical behavior, and continuous learning.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.