Senior Scientists - Formulation Development wanted by Particle Sciences, Inc. (a Agno Pharma company), Bethlehem, PA.

Conduct independent research, define scientific objectives, plan, and execute projects for developing innovative drug products leveraging expertise in complex sterile and non-sterile manufacturing technologies such as lyophilization, long acting injectables, nanoparticles, amorphous solid dispersions, and aseptic processing with minimal supervision. Serve as a subject matter expert (SME) in physical and solid-state characterization techniques, including DSC, TGA, XRPD, particle size distribution, and zeta potential, providing guidance to the team on interpretation of the analytical results. Confer with technical team to develop scale-up manufacturing processes leveraging knowledge in complex aseptic manufacturing processes, cGMP, and regulatory standards. Apply Quality by Design (QbD) frameworks to plan and execute process development, including design of experiments (DoE), risk assessments, and process performance evaluation ensuring process reproducibility and cGMP compliance. Facilitate and coordinate work across multiple departments within the site including engineering, analytical development, quality assurance, quality control, manufacturing, business development, and project management. Mentoring junior formulators on equipment and complex process technologies including troubleshooting. Writing technical documentation including master batch records (MBRs), master formulation records (MFRs), Standard Operating Procedures (SOPs), cGMP documentation, and Product Development Reports (PDRs).

Must have a Master's degree in Pharmaceutical Sciences, Industrial Pharmacy or a related field, plus three (3) years of experience in any occupation which includes the required experience and skills. In lieu of a Master's degree and three (3) years of experience, will accept a Bachelor's degree in Pharmaceutical Sciences, Industrial Pharmacy or a related field, plus five (5) years of progressive experience.

Experience must include:

3 or 5 years (depending on degree) of Nanotechnology experience;

3 or 5 years (depending on degree) of Amorphous Solid Dispersion experience;

3 or 5 years (depending on degree) of long acting injectable and ophthalmic product development experience;

3 or 5 years (depending on degree) of cGMP experience (Sterile and Non-Sterile); and

3 or 5 years of experience (depending on degree) formulating IND, NDA, ANDA, and 505(b)(2) drug products.

If interested, please send resume to PSI-HR@particlesciences.com. Refer to job ID# PSI22 in subject line.

Particle Sciences, Inc.

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Senior Scientists - Formulation Development