MS&T Scientist

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

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

Key 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 Critical Quality Attributes (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 closely with Manufacturing, Engineering, Quality, Validation, Planning, and Supply Chain teams.
• Ensure activities comply with GMP/cGMP and quality requirements.

Preferred Qualifications

• MS&T, Process Development, or Pharmaceutical Manufacturing experience.
• 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.

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Benefits:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.