Senior Scientist, Technical Services - Process Excellence

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

Benefits offered by this job

Comprehensive medical, dental, and via

Annual bonus opportunity

Tuition reimbursement

Employee wellness programs

Employee stock program

Career growth and advancement

Job summary

Astrix Inc. in Seymour, IN, is seeking a Principal Scientist, Technical Services to serve as the technical expert for solid oral dosage products across the lifecycle.

You will drive development, tech transfer, validation, and continued process improvements in a fast-paced manufacturing environment. The role emphasizes collaboration with Manufacturing, Quality, Regulatory Affairs, and R&D, performing root cause analyses, and guiding troubleshooting and documentation.

Qualifications

• Requires a degree in a pharmaceutical science or related field with advanced study preferred.
• At least 15+ years of pharmaceutical manufacturing experience in solid oral dosage products.
• Strong knowledge of cGMP, FDA guidelines, and ICH requirements.

Responsibilities

• Lead technical support for solid oral dosage manufacturing and process improvements.
• Drive process development, scale-up, technology transfers, and process validation.
• Investigate deviations and perform root cause analyses with corrective actions.
• Develop and review validation protocols, reports, investigations, and batch records.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Validation, and R&D teams.
• Analyze manufacturing data using statistical tools to optimize yields and performance.
• Mentor junior scientists and support cross-functional project teams.
• Support regulatory inspections and FDA/cGMP compliance initiatives.
• Participate in project planning and ensure timely delivery of initiatives.
• Provide after-hours technical support when needed.

Skills

Process development

Technology transfer

Process validation

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in Pharmaceutical Sciences/Chemistry/Chem Eng or related

MS or PhD preferred

Job description

Astrix Inc. in Seymour, IN, is seeking a Principal Scientist, Technical Services to serve as the technical expert for solid oral dosage products across the lifecycle.

You will drive development, tech transfer, validation, and continued process improvements in a fast-paced manufacturing environment. The role emphasizes collaboration with Manufacturing, Quality, Regulatory Affairs, and R&D, performing root cause analyses, and guiding troubleshooting and documentation.