Job Description
As part of our Company’s Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites.
The SDPC group is the division’s leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel vaccines, biologics, pharmaceutical products, and combination products. The SDPC group supports the growing pipeline of diverse products and evolving technologies.
We are seeking an Associate Principal Scientist to advance and commercialize the intravitreal (IVT) pipeline products. As a member of the drug product team, the Associate Principal Scientist will be accountable for planning and execution of activities associated with commercial design, characterization, and transfer of process to commercial manufacturing sites.
This position may require travel up to 25%. Must be able to travel for this position.
Accountabilities and Responsibilities for this position include but are not limited to the following:
- Technical guidance and oversight of late-stage product and process development.
- Manages 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, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
- Develops a robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.
- Develops a process and product development plan. Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
- Drives the design and execution of process characterization activities. Ensures fit-for-purpose scale-down models are developed and employed. Oversees lab studies as required to ensure ‘right first time’.
- Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.
- Responsible for commercial site technology transfer and facility fit. Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls, and parameter classification.
- Influences primary packaging decisions. Drives and influences process demonstration and qualification (PPQ) strategy.
- Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy (including filing storyboard) and filing readiness and supports preparations for agency meetings. Authors and review regulatory filings.
- Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
- Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitors performance and recommends schedule changes, cost adjustments or resource additions.
- Provides a regular summary of progress against development plan, key program and technical risks and risk level, mitigation strategies, and how success will be determined.
- Serves on cross functional teams and support strategic initiatives.
- Leads agile implementation of new/improved business processes in partnership with colleagues in Research Laboratories and the Manufacturing Division.
- Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations.
- Provides mentorship, technical oversight, and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
- Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity, and inclusion.
- Potentially manages a small group of individual contributors (professional and contract employees).
Minimum Education Requirements and Experience:
- Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience; OR
- Master of Science (M.S.) degree in chemical engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of relevant experience; OR
- Ph.D. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with three (3) years of relevant experience.
Preferred Experience and Skills:
- Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
- Experienced in intravitreal/ophthalmic manufacturing practices and working in low particulate, low bioburden/endotoxin environments.
- Experienced in sterile drug product fill finish manufacturing practices including working with low volume fills and small batch scale.
- Knowledge or experience with single use system technologies.
- Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
- Experience with utilization of QbD principles to process development and life cycle management.
- Experience in Design of Experiment (DoE) and statistical data analysis.
- Experience in authoring and reviewing CMC regulatory documentation.
- Analytical problem-solving skills and competency in technical writing.
- Project management and activities management skills (dashboards, activity trackers).
- Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
- Experience in Design of Experiment (DoE) and statistical data analysis.
- Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
- Experience in Data Analytics.