Sr. Formulation Scientist

Sr. Formulation Scientist

• Conduct literature research to support R&D drug product development.
• Develop pharmaceutical and medical device formulas, generate stability protocols and data to support product expiration dating.
• Perform cGMP laboratory testing to support formulation development.
• Proficiently scale up and transfer technology for non-sterile OTC liquid formulations while ensuring strict adherence to CGMP standards.
• Generate and execute protocols for product transfer, reviewing reports and documents for compliance with requirements.
• Take responsibility for developing, documenting, and contributing to manufacturing specifications, bills of materials, SOPs, and work instructions.
• Enhance drug product stability and compatibility, actively participating in the stability program by conducting tests on experimental batches and finished products.
• Manage process validation including mixing studies, hold studies, & stability studies, cleaning validation, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment.
• Participate in the development of sterile and non-sterile products, including the design, optimization, and scale-up of formulations for Blow Fill Seal (BFS) and Blow Fill Cap (BFC) manufacturing processes.
• Perform High-Performance Liquid Chromatographic (HPLC), Fourier transform infrared (FTIR), and wet chemistry testing on raw materials, finished products, and stability samples.
• Provide chemical related safety support to the safety officer and handles waste stream related to chemical waste.
• Assume accountability for work performed, generating, reviewing, and approving reports and documents for compliance in support of the Quality System, as required.

Require a Doctor of Pharmacy degree and 2 years of experience in a pharmaceutical, medical device facility, or research facility/university. Education/experience in understanding the chemistry of drug products for the design and development of formulations and processes, scaling up for manufacturing of batches. Experience/understanding of regulatory guidelines and quality assurance standards.