MS&T Scientist—Transfer & Process Development (Sterile)

Intellectt Inc; Kansas; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

401(k) plan

PTO

Job summary

Intellectt Inc in Kansas seeks an experienced MS&T Scientist to support product/technology transfers, process development, optimization, and commercial manufacturing for pharmaceutical products, including small-molecule and sterile/aseptic products.

The role will lead transfer activities, collaborate with Quality, Validation and Production teams to ensure GMP/cGMP compliance, and deliver well-documented engineering studies and development batches to enable robust manufacturing.

Qualifications

• Experience with product transfers and commercial manufacturing.
• Experience with sterile/aseptic manufacturing is highly preferred.
• Strong knowledge of CQAs, process parameters, process validation, and GMP/cGMP.
• Excellent technical writing, project management, and cross-functional communication skills.

Responsibilities

• Lead product and technology transfer activities from development to commercial manufacturing.
• Support process development, optimization, product maintenance, and manufacturing improvements.
• Develop and execute technical protocols, reports, engineering studies, development batches, and manufacturing documents.
• Prepare quality risk assessments and identify product/process risks.
• Define CQAs and acceptable process parameter ranges.
• Support process characterization, validation, and testing strategies with Quality and Validation teams.
• Lead technical assessments covering feasibility, timelines, resources, costs, and project requirements.
• Drive manufacturing efficiency and process improvement initiatives.
• Collaborate with Manufacturing, Engineering, Quality, Validation, Planning, and Supply Chain teams.
• Ensure activities comply with GMP/cGMP and quality requirements.

Skills

Product transfers

Process development

Process optimization

GMP/cGMP knowledge

Sterile/aseptic manufacturing

Technical writing

Cross-functional communication

Education

Master's degree in MS&T or related field

Job description

Intellectt Inc in Kansas seeks an experienced MS&T Scientist to support product/technology transfers, process development, optimization, and commercial manufacturing for pharmaceutical products, including small-molecule and sterile/aseptic products.

The role will lead transfer activities, collaborate with Quality, Validation and Production teams to ensure GMP/cGMP compliance, and deliver well-documented engineering studies and development batches to enable robust manufacturing.