Principal Scientist, Technical Services

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

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.

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.