Lead, Sterile Injectable Product Development

Tailstorm-Health-Inc; Chandler (AZ); On-site; USD 120,000 - 125,000; Full time

Job summary

Tailstorm-Health-Inc in Chandler, AZ is hiring an Associate Director of Product Development to lead sterile injectable formulation, process development, scale-up, and technology transfer from feasibility through commercialization, ensuring sound development strategies and regulatory compliance.

You will provide technical leadership for QbD-based development with vials and prefilled syringes, collaborating with Manufacturing, Quality, Regulatory Affairs, and external partners to accelerate

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or a related scientific discipline.
• 8+ years of progressive experience in pharmaceutical product development, formulation development, or process development.
• Demonstrated experience developing sterile injectable products for commercial manufacturing.
• Strong knowledge of aseptic processing, sterilization technologies, formulation science, and process development.
• Experience applying QbD principles, risk assessments, and DoE.
• Working knowledge of FDA regulations, CGMP requirements, and ICH guidelines.
• Experience with technology transfer, validation activities, and commercial manufacturing support.
• Strong project management, problem-solving, and technical leadership capabilities.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Prepare feasibility assessments, development plans, timelines, and cost estimates for leadership review.
• Evaluate product opportunities and development strategies to support portfolio expansion and commercialization objectives.
• Identify development risks and recommend mitigation strategies to ensure successful project execution.

Skills

Project management

Cross-functional leadership

Regulatory compliance

QbD principles

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or related field

Job description

Tailstorm-Health-Inc in Chandler, AZ is hiring an Associate Director of Product Development to lead sterile injectable formulation, process development, scale-up, and technology transfer from feasibility through commercialization, ensuring sound development strategies and regulatory compliance.

You will provide technical leadership for QbD-based development with vials and prefilled syringes, collaborating with Manufacturing, Quality, Regulatory Affairs, and external partners to accelerate