Lead, Sterile Process Engineering & Platform Development

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

GlaxoSmithKline is seeking a senior DP Process Engineer to lead sterile process engineering activities for development and commercial supply. You will drive design, scale‑up, technology transfer and modeling across formulation, analytics, manufacturing and external partners, delivering robust sterile processes for patient‑focused products.

You will collaborate with R&D, pilot plants and global manufacturing sites, author regulatory sections, and guide platform development while ensuring quality,

Qualifications

• BS in science/engineering with 10+ years in sterile drug product development.
• Experience with aseptic processing, sterile filtration, filling/stoppering and lyophilization.
• Experience with data integrity principles and mentoring staff in study design, execution, reporting.

Responsibilities

• Lead DP process engineering and analytics in a multi-disciplinary development team to scale and transfer sterile processes.
• Provide expertise in process development, characterization, scale-up, technology transfer, and modelling for sterile products.
• Identify and deploy in silico tools to accelerate DP development; lead technical transfer and governance processes.
• Contribute to CMC team planning and coordinate PE&A activities to support objectives.
• Author regulatory sections relevant to Process Engineering platforms (IND/IMPD, etc.).
• Lead platform development workstreams to establish new manufacturing platforms and control strategies.
• Deliver robust platform performance across the portfolio and serve as the unit operation expert.

Skills

Aseptic processing

Sterile filtration

Filling/stoppering

Lyophilization

Data integrity

Mentoring staff

Scientific study design

Technical leadership

Cross-functional collaboration

Education

Bachelor of Science in Engineering

PhD or MSc

Job description

GlaxoSmithKline is seeking a senior DP Process Engineer to lead sterile process engineering activities for development and commercial supply. You will drive design, scale‑up, technology transfer and modeling across formulation, analytics, manufacturing and external partners, delivering robust sterile processes for patient‑focused products.

You will collaborate with R&D, pilot plants and global manufacturing sites, author regulatory sections, and guide platform development while ensuring quality,