Principal Scientist, Technical Services

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

Pay Rate Low: 110000 | Pay Rate High: 150000

At this time, Astrix cannot transfer nor sponsor a work Visa for this position.

Relocation assistance is not available for this position.

This is an exciting opportunity for a seasoned pharmaceutical professional to join a well-established pharmaceutical manufacturer as a Principal Scientist, Technical Services. In this highly visible individual contributor role, you'll serve as the technical expert supporting solid oral dosage products throughout the product lifecycle, from process development and technology transfer to commercial manufacturing support and continuous process improvement.

Pay: $110k-$150k
Schedule: M-F 8a-5p
Type of Job: Direct Hire
Location: Seymour, IN: Located just one hour from both Louisville, KY and Indianapolis, IN, offering the affordability of a smaller community with convenient access to two major metropolitan areas.

Benefits Offered:

• Comprehensive medical, dental, and vision insurance.
• Annual bonus opportunity.
• Tuition reimbursement.
• Employee wellness programs.
• Employee stock program.
• Career growth and advancement opportunities

Principal Scientist, Technical Services Daily Tasks: What you will do:

• Lead technical support for commercial solid oral dosage products, ensuring efficient manufacturing operations and continuous process improvements.
• Drive process development, scale-up activities, technology transfers, and process validation for new and existing products.
• Investigate manufacturing deviations and product quality concerns by performing root cause analyses and implementing effective corrective actions.
• Develop, review, and approve technical documentation, including validation protocols, reports, investigations, change controls, batch records, and regulatory submissions.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Validation, and R&D teams to resolve technical challenges and support product launches.
• Analyze manufacturing data and apply statistical tools to optimize processes, improve yields, and enhance product performance.
• Provide technical guidance and mentorship to junior scientists while serving as a subject matter expert for cross-functional project teams.
• Support regulatory inspections, internal audits, and compliance initiatives to maintain FDA and cGMP standards.
• Participate in project planning, prioritize multiple technical initiatives, and deliver results within established timelines.
• Provide occasional after-hours technical support for critical manufacturing activities when needed.

Principal Scientist, Technical Services Qualifications/Requirements:

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree (MS or PhD) preferred.
• 15+ years of pharmaceutical manufacturing experience with a strong focus on solid oral dosage products.
• Demonstrated expertise in process development, technology transfer, process validation, and commercial manufacturing support.
• Strong knowledge of cGMP regulations, FDA guidelines, ICH requirements, and pharmaceutical quality systems.
• Experience leading complex manufacturing investigations, root cause analyses, and continuous improvement initiatives.