Scientist, Engineering

Job Description

 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 Vaccines, Biologics and sterile pharmaceutical products. It is the divisions leader in sterile product and process development, responsible for 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 science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel Vaccines, Biologics, 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 scientists/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.  

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

• Serves on cross functional drug product (DP) working groups and supports 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, Pre-Approval Inspection (PAI) 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 development and 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, Mechanical Engineering, Bio-Engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2 years of relevant experience; or 

• Master’s degree in chemical engineering, Bio-Engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field. 

Required Experience and Skills:

• Relevant academic, internship, co-op, or …