Product Development Specialist
This position is key in the Pharmaceutical industry. Managing multiple complex product development programs from concept through commercial launch is a crucial requirement.
* Lead end-to-end development of new products, including design, process development, scale-up, and validation.
* Apply Quality by Design (QbD) and Design of Experiments (DoE) to optimize formulation and manufacturing processes.
* Balance priorities and resources across projects while managing multiple development programs.
* Oversee technology transfer from development to pilot and commercial.
* Ensure smooth process validation and commercial readiness.
* Provide technical leadership in troubleshooting and root-cause investigations.
* Contribute to regulatory submissions with detailed technical documentation.
* Identify and implement process improvements that enhance product performance, reduce costs, and improve manufacturability.
* Mentor junior engineers and scientists, fostering technical excellence and collaboration.
* Support audits as a technical subject matter expert.
Requirements:
* Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Process Engineering, or related field.
* 5-7 years experience in pharmaceutical product or process development with program management skills.
* Proven experience in NPI, process scale-up, and commercial technology transfer.
* Strong understanding of cGMP, regulatory requirements, and pharmaceutical lifecycle management.