Scientist, Engineering Full-time NEW

Scientist, 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, and Sterile pharmaceutical products. It is the division's leader in sterile product and process development, responsible for commercialization activities including process development, 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 Biologics, and Pharmaceutical products and combination products.

The Scientist is a drug product commercialization scientist/engineer, responsible for these key activities within the Sterile Drug Product Commercialization department. Our engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

This position may require travel up to 10%; Must be able to travel for this position. This position requires on-site presence at the West Point, PA.

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

• Serve on drug product (DP) process characterization teams, designing and executing multivariate product and process development studies.
• Support cross functional DP working groups and also 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.
• Responsible for the design and execution of DP commercialization studies, new product introduction and process validation at commercial sites.
• Contributes to development of fit-for-purpose scale-down models. 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.
• Contributes to establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.

Minimum Education Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2 years of relevant experience; or
• Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field.

Required Experience and Skills:

• 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

• Technical experience in process characterization, process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
• Knowledge of combination product development.
• Working knowledge of regulatory requirements or 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
• Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products

Required Skills: Biochemistry, Biopharmaceuticals, Biopharmaceutics, Cell Culture Techniques, Clinical Manufacturing, Data Analysis, Detail-Oriented, Downstream Process Development, Experimentation, GMP Compliance, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Manufacturing Process Validation, Microbiology, Pharmaceutical Process Development, Platform Engineering, Process Scale Up, Process Validation, Statistical Process Control (SPC), Technical Writing, Technology Transfer, Upstream Process Development

Preferred Skills: