BPI Labs

We are looking for a Formulation Scientist to work on lifesaving Sterile Drug Products in the form of Pre-fill Syringes, Vials, and Cartridges in accordance with Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA) and other global regulatory agencies.

Job-Specific Responsibilities / Functions

• Design and execute studies related to pre-formulation and formulation of parenteral products, including solubility, pH solution stability, and delivery of the product. This includes experimental design, data evaluation, generation of scientific reports, and coordination of studies with other technical groups.
• Responsible for the development and evaluation of proposed formulations, processing, compounding, filtration procedures, and selection of container/closure systems.
• Container closure, components (filters, tubing, etc.), product mixing, holding, filtration equipment selection, and perform compatibility studies.
• Perform/coordinate filter validation studies, such as microbial challenge studies and filter integrity testing validations.
• Perform/coordinate product sterilization cycle development and support validation in execution of such studies.
• Manufacture stability batches, coordinate stability testing, review data, and filing.
• Participate in the scale-up and technology transfer process, and process validation in collaboration with the Manufacturing Plant and Production staff.
• Investigate, troubleshoot, and resolve issues associated with formulation studies and/or R&D pilot manufacturing.
• Collaborate with internal cross-functional staff including Process Engineers, Manufacturing Operators, Quality Control, Microbiology, Validation, and Quality Assurance to coordinate pilot, registration, and commercial batch manufacturing in support of cGMP.
• Interact professionally with external clients and customers.
• Write, review, and approve Standard Operating Procedures (SOPs).
• Write, review Protocols, coordinate execution, review test data, and final reports.
• Write, review, and approve Batch Manufacturing Records and sampling/testing protocols.
• Participate in cross-functional teams in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness.

Qualifications

• Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
• Strong interest in formulation development, drug delivery, and injectables.
• Knowledge of pharmaceutical product development and regulatory standards (preferred, not required).
• Excellent problem-solving, communication, and teamwork skills.
• Self-motivated with a proactive, hands-on approach and eagerness to learn.
• Ability to troubleshoot equipment problems and perform complex system tests.
• Must be able to quickly learn and apply new software and technologies and assimilate new methods to design workflows and specifications.
• Knowledge of Sterile Drug Products and cGMP manufacturing environment.
• Able to work in pharmaceutical aseptic cleanrooms in a GMP manufacturing environment as part of a two-shift operation.