Biologics Process Transfer Lead

Caraway Therapeutics, Inc.; United States; On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Bonus eligible

Job summary

Merck is seeking an Associate Director for Process Development Large Molecules to lead a dedicated technology transfer team in the US. You will develop robust processes and transfer pipelines from R&D to manufacturing, collaborating with R&D, operations, quality, and regulatory to meet file and launch targets.

The role requires a BS in a relevant field, 8+ years of post-graduate experience (including 3+ years of management) and strong knowledge of biopharma regulations.

Qualifications

• Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field.
• Minimum of 3 years of direct management experience.
• Minimum four years of relevant experience in technology transfer, process development, technical operations, or manufacturing operations within a regulated biopharmaceutical environment.
• Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines.

Responsibilities

• Process Development – develop robust processes and right-first-time tech transfer from R&D to operations for antigens and final products.
• People Management – build and coach a high-performing technology transfer team with clear objectives and feedback.
• Technical Excellence – drive data-driven decisions, risk mitigation, and lab experiments to reduce COGs and increase robustness.
• Strategic Leadership – manage strategic initiatives and align with Regional Technology Hoshin goals.

Skills

Biopharmaceutical Industry

Coaching Employees

Decision Making

Life Sciences Industry

Life Sciences R&D

People Leadership

Process Development

Technical Operations

Technology Transfer

Education

Bachelor of Science in Chemical Engineering

Job description

Merck is seeking an Associate Director for Process Development Large Molecules to lead a dedicated technology transfer team in the US. You will develop robust processes and transfer pipelines from R&D to manufacturing, collaborating with R&D, operations, quality, and regulatory to meet file and launch targets.

The role requires a BS in a relevant field, 8+ years of post-graduate experience (including 3+ years of management) and strong knowledge of biopharma regulations.