Senior Lead, Sterile Injectable Product Development

RXinsider LTD.; Chandler (AZ); On-site; USD 180,000 - 240,000; Full time

Job summary

RXinsider LTD. seeks Associate Director, Product Development to lead sterile injectable formulation, process development, and tech transfer from feasibility to commercialization.

You will apply QbD, DoE, and risk-based methods, collaborate with Manufacturing, QA, Regulatory, and external partners, and guide teams to deliver scalable, compliant processes. A strong background in aseptic processing and FDA CGMP is required; leadership, project management, and cross-functional communication are

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

• Lead formulation development of sterile injectable solutions in vials and prefilled syringes.
• Design and execute pre-formulation studies, including solubility assessments, pH stability profiling, and excipient compatibility evaluations.
• Conduct forced degradation studies to characterize degradation pathways and support formulation and packaging decisions.
• Apply Quality by Design (QbD) principles and risk-based methodologies in accordance with ICH Q8(R2) and Q9 guidelines.
• Identify critical quality attributes (CQAs), critical process parameters (CPPs), and design robust development strategies using Design of Experiments (DoE).
• Develop compounding, mixing, filtration, and filling processes suitable for commercial-scale manufacturing.
• Establish sterilization strategies, including terminal sterilization and aseptic processing approaches.
• Support filter selection, compatibility studies, and bacterial retention evaluations.
• Collaborate with Production, Engineering, Quality Assurance, and Quality Control to ensure scale-up and process implementation.
• Lead engineering, feasibility, pilot, and validation batches.
• Author development reports, formulation records, manufacturing batch records, and supporting documentation.
• Manage technology transfer activities from development through commercial manufacturing.
• Participate in change control, deviation investigations, and continuous improvement initiatives.

Skills

QbD principles

DoE

Aseptic processing

Sterile injectable development

Project management

Education

Bachelor's degree in Pharmaceutical Sciences / Chemistry / Chemical Engineering / Biomedical Engineering

Master's or PhD preferred

Job description

RXinsider LTD. seeks Associate Director, Product Development to lead sterile injectable formulation, process development, and tech transfer from feasibility to commercialization.

You will apply QbD, DoE, and risk-based methods, collaborate with Manufacturing, QA, Regulatory, and external partners, and guide teams to deliver scalable, compliant processes. A strong background in aseptic processing and FDA CGMP is required; leadership, project management, and cross-functional communication are