Associate Principal Scientist, Engineering

Overview

Associate Principal Scientist, Biologics, Sterile Drug Product Commercialization. Part of the Manufacturing Division, the Sterile Drug Product Commercialization group provides technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics and combination products. The group leads sterile product and process development, late-stage commercialization activities including process scale-up, technology transfer, process validation, regulatory submissions, and support of manufacturing investigations.

We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics pipeline programs. As a member of the biologics drug product team, the role focuses on process characterization, scale-up, transfer and process validation activities.

• Lead and/or participate in cross-functional biologics drug product (DP) working groups; manage DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection (PAI) readiness, approval, launch and post-launch support.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Drive strategic initiatives (technical and/or business process related) within the department and with partner groups to enable more efficient and rapid commercialization of innovative products.
• Provide mentorship, technical oversight and strategic guidance to employees; use advanced experience to guide others in addressing non-routine or difficult issues.
• Develop process and product development plans; influence decisions related to primary packaging and combination product design.
• Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites; develop fit-for-purpose scale-down models.
• Establish and validate platform engineering and scientific models for sterile product and process commercialization; innovate and drive best practices for tech transfer at commercial sites, facility fit, and DP control strategy.
• Classify process parameters, performance parameters, operating ranges, and in-process controls; drive and influence PPQ and shelf-life strategies.
• Influence CMC regulatory strategy; be accountable for DP CMC sections of filings; review regulatory strategy and filing readiness; support preparations for agency meetings; author and review regulatory submissions.
• Drive continuous process optimization toward standardized platforms for liquid, lyophilized, and combination product presentations.
• Establish and foster a culture of high performance, innovation, learning, empowerment, diversity and inclusion.
• Travel up to 25% as required.

Education – Minimum Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or

• M.S. in same fields with 8 years of relevant experience; or

• Ph.D. in same fields with 4 years of relevant experience.

Experience and Skills
:

• Experience with drug product process development, optimization, and/or process characterization of biologics.
• Experience with at-scale biologics drug product manufacturing and fill-finish operations; technical expertise in sterile drug product fill-finish for large molecules; laboratory and/or fundamental models for key unit operations.
• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Excellent oral and written communication; ability to articulate process science to drive decision making within a multi-disciplinary team.
• Preferred: experience in biologics drug product fill-finish process optimization, scale-up and technology transfer; operations experience in manufacturing potent and sterile drug products at pilot or commercial scale; late-stage commercialization experience; understanding of regulatory requirements and Quality by Design;…