Senior Development Engineer, Sterile BFS Process Scale-Up

Woodstock Sterile Solutions

Woodstock, Northern (IL, KY)

Hybrid

USD 110,000 - 130,000

Full time

3 days ago

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Job summary

Woodstock Sterile Solutions is seeking a Senior Development Engineer to lead pre-development through scale-up and commercialization of BFS formulations and processes. You will collaborate with customer scientists, development and process engineers, and cross-functional teams to translate concepts into robust, scalable BFS processes.

The role requires strong knowledge of Design of Experiments, Quality by Design, risk assessment, and statistical tools to deliver technically sound solutions, while

Qualifications

Seven or more years of pharmaceutical drug product process development experience.
Experience in sterile processing or liquid drug formulation preferred.
Lean and/or Six Sigma experience beneficial.

Responsibilities

Lead formulation development, feasibility, scale-up, tech transfer and commercialization.
Provide technical direction and mentoring to development engineers.
Define experimental designs, process parameters and acceptance criteria.
Develop scalable, robust processes meeting product specifications.
Support regulatory submissions and customer filings as needed.

Skills

Mathematics

Statistical analysis

Quality by Design

Problem solving

Technical writing

Communication

Leadership

Education

B.S. in Chemistry/Pharmacy/Engineering

M.S. or Ph.D. in Chemistry/Pharmacy/Engineering

Tools

CAD

P&IDs

Design software

Job description

The role requires strong knowledge of Design of Experiments, Quality by Design, risk assessment, and statistical tools to deliver technically sound solutions, while

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