Senior Principal Engineer/Associate Director, Drug Product MSAT

About the 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.

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.

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.

Pay

$180,000 - $195,000 USD