Associate Principal Scientist, Engineering- Biologics, Sterile Drug Product Commercialization

* 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 (Pre‐Approval Inspection) readiness, approval, launch and post‐launch 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.
* B.S. in Chemical Engineering, Biochemical Engineering  Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
* Master's degree in Chemical Engineering, Biochemical Engineering  Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or
* Ph.D. in Chemical Engineering, Biochemical Engineering  Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience
* 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 related manufacturing processes for large molecules, including 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 skills.  Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment
** Preferred Experience and Skills
*** Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial
* Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
* Experience with late-stage commercialization of biologics programs
* Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
* Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile…