As part of Our Company's 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.
Requirements
- Leads and/or serves on cross functional biologics drug product (DP) working groups and 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 (PreāApproval Inspection) readiness, approval, launch and postālaunch support.
- Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
- Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
- 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.
- Develops a process and product development plan. Influences decisions related to primary packaging and combination product design.
- Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
- Ensures fit-for-purpose scale-down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
- Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in-process controls. Drives and influences process demonstration and qualification (PPQ) and shelf-life strategies.
- Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions.
- Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
- Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Benefits
- Medical, dental, vision healthcare and other insurance benefits
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
