Associate Scientist Engineering

About the Role

The Associate Scientist will be part of the Vaccines team within Sterile Drug Product Commercialization (SDPC). The SDPC group provides technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products.

Key Responsibilities

• Support cross-functional DP working groups from process development through Process Performance Qualification (PPQ) and regulatory filing, including registration stability study execution, process characterization study planning and execution, technology transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection (PAI) support, launch and post-launch support.
• Designs, authors, and executes DP commercialization studies.
• Develops and authors technical documents including process design, definition, qualification, and validation.
• Contributes to development of fit-for-purpose scale-down models.
• Ensures commercialization programs meet requirements related to science, quality, reliability, safety, schedule and cost.
• Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy, including the classification of process parameters, performance parameters, operating ranges, and in-process controls.
• Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans.
• Contributes to a culture of safety, high performance, out-of-the-box thinking, innovation, continuous learning, empowerment, diversity and inclusion.
• This position may require travel up to 10%.
• This position is required to be on-site four days per week.

Requirements & Tech Stack

• B.S. or higher degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field.
• Excellent oral and written communication skills.
• Ability to effectively articulate understanding of process science to drive decision making in a multi-disciplinary team environment.

Preferred Qualifications

• Technical experience in large molecule drug product process characterization, fill finish 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 and other sterile drug products.

Required Skills

• Adaptability
• Data Analysis
• Experimentation
• Laboratory Techniques
• Manufacturing
• Process Capability Analysis
• Process Definition
• Process Design
• Process Development (PD)
• Process Engineering
• Product Formulation
• Statistical Data Analysis
• Technical Reviews
• Technical Writing
• Technology Transfer
• Timeline Management
• Writing Technical Documents

Preferred Skills

• N/A

Note: Travel requirements are listed as up to 25% in the raw data, but the specific requirement for this position is stated as up to 10%.