Principal Scientist, Engineering Full-time

Principal Scientist, Biologics, Sterile Drug Product Commercialization

As part of Our Company's Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for biologics.

It is the division's leader in sterile product and process development, responsible for late-stage 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 biologics and combination products.

We are seeking an experienced Principal Scientist to advance and commercialize biologics pipeline programs. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.

Accountabilities and Responsibilities for this position include but are not limited to the following:

• Execute and provides oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation
• 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.

Travel:

This position may require travel up to 25%; Must be able to travel for this position.

Position Qualifications:

Education Minimum Requirements

• B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
• Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
• Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience

Required Experience and Skills:

• Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs and/or fusion proteins)
• Experience with at scale biologics drug product manufacturing and fill finish operations
• Experience with late-stage commercialization of biologics programs
• 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 commercialization of biologics programs through PPQ and launch
• Working knowledge in analytical methods and product attributes for biologics
• 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 dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
• Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
• Experience in Data Analytics, Computer Modeling, and Digital Applications.
• Working understanding of analytical methods to characterize biologics and other sterile drug products

Required Skills:

Accountability, Biochemistry, Biologics, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Manufacturing, Cross-Functional Teamwork, Decision Making, Design Management, Driving Continuous Improvement, Drug Product Development, Drug Product Manufacturing, Good Manufacturing Practices (GMP), Manufacturing Processes, Manufacturing Scale-Up, Mentorship, Multivariate Data Analysis, New Product Introduction Process, Planning, Process Characterization, Process Control, Process Design, Process Optimization {+ 4 more}

Preferred Skills:

Biological Manufacturing