Associate Scientist Engineering

Job Description

Associate Scientist - Sterile Drug Product Commercialization (SDPC)

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

The Associate Scientist in this position will be part of the Vaccines team within Sterile Drug Product Commercialization.

As part of our manufacturing division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. It is 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 vaccines, biologics, and pharmaceutical products.

Sterile Drug Product Commercialization is part of the larger Global Science, Engineering, and Commercialization organization. With our extensive range of facilities and environments, our scientists and engineers have career opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Responsibilities:

• Support cross-functional DP working groups from process development through Process Performance Qualification (PPQ) and regulatory filing. Examples include 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. Includes 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%; must be able to travel for this position.
• This position is required to be on-site four days per week.

Qualifications:

Required

• 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

• 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:

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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