Lead Technical Scientist, Solid Dosage Manufacturing

Astrix; Seymour (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and视ion

Annual bonus opportunity

Tuition reimbursement

Employee wellness programs

Employee stock program

Career growth and advancement

Job summary

Astrix in Seymour, IN seeks a Principal Scientist, Technical Services to act as the technical expert supporting solid oral dosage products throughout the lifecycle. You will lead process development, scale-up activities, technology transfers, and ongoing manufacturing support in a high-visibility role.

The ideal candidate has 15+ years in pharmaceutical manufacturing with solid oral dosage focus and strong knowledge of cGMP, FDA guidelines, and ICH.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field; MS or PhD preferred.
• 15+ years of pharmaceutical manufacturing experience with solid oral dosage focus.
• Strong knowledge of cGMP, FDA guidelines, ICH, and quality systems.

Responsibilities

• Lead technical support for commercial solid oral dosage products and drive continuous improvement.
• Oversee process development, scale-up, technology transfer, and validation activities.
• Investigate deviations and quality concerns with root cause analyses and corrective actions.
• Develop, review, and approve technical documentation including validation protocols, reports, and change controls.
• Collaborate cross-functionally with Manufacturing, Quality, Regulatory Affairs, Validation, and R&D teams.
• Analyze manufacturing data to optimize processes and yields; mentor junior scientists.
• Support regulatory inspections and internal audits to maintain compliance.
• Participate in project planning and prioritize multiple technical initiatives.
• Provide occasional after-hours technical support when needed.

Skills

Process development

Technology transfer

Process validation

Root cause analysis

Data analysis

Education

Bachelor's degree

MS/PhD preferred

Job description

Astrix in Seymour, IN seeks a Principal Scientist, Technical Services to act as the technical expert supporting solid oral dosage products throughout the lifecycle. You will lead process development, scale-up activities, technology transfers, and ongoing manufacturing support in a high-visibility role.

The ideal candidate has 15+ years in pharmaceutical manufacturing with solid oral dosage focus and strong knowledge of cGMP, FDA guidelines, and ICH.