Senior Principal Engineer/Associate Director, Drug Product MSAT

Overview of Role:

We are seeking a highly experienced and strategic Senior Principal Engineer/Associate Director of MSAT - Drug Product to join the CMC team and be a key contributor to ongoing process development, technology transfer, process validation, BLA/MAA/IND/IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading DP Tech transfer(s), authoring technical reports and on providing content to the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring significant experience in biologics manufacturing, sterile drug product operations, and regulatory expectations.  

Role and Responsibilities:

• Provide technical expertise for phase-appropriate drug product process development, characterization, validation, and technology transfer for sterile drug product (DP). 
• Assess and manage process risks arising from manufacturing or process changes. 
• Serve as a primary or supporting technical interface with external CDMOs and internal manufacturing teams.  
• Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle.  
• Support and guide execution of clinical and commercial batch manufacturing activities to meet development and supply timelines.  
• Assist in the authorship, data verification, update, and/or review of regulatory filings. 
• Provide technical feedback during regulatory agency inquiries.  
• Lead PPQ execution and manufacturing oversight in alignment with GMP and quality system requirements through person in plant.  
• Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution.  
• Ensure GMP compliance across all assigned activities.  
• Support audits, inspections, and continuous improvement initiatives.  
• Manage process deviation investigations and change controls. 
• Travel as needed to support technology transfer, process scale-up, and collaboration with external partners. 
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree in chemical engineering, biotechnology, pharmaceutical science, or a related field required. Advanced degree (Masters or PhD) preferred. 
• Minimum of 10+ years of relevant experience within the life sciences industry  
• Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing with a focus on sterile drug product and late-phase development (preferably mAbs) is essential.  
• Experience with technology transfer across different systems, scales, and sites is highly valued 
• Experience in late-stage process development, characterization and validation is highly valued 
• IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred 
• Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus 
• Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs. 
• Excellent attention to detail and organizational skills, with a focus on quality and technical excellence. 
• Good information management and data organization skills 
• Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators. 
• A track record of working under pressure and delivering high-quality results to tight deadlines.