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.
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-NM1
