Formulation Development Scientist

Formulation Scientist 

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 of stability batches, stability testing coordination, review data, and filing.
• Participate in the scale-up and technology transfer process, 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 (SOP).
• Write, review Protocols, coordinate to execute, 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.

Who You Are

• Bachelor/Master degree in Pharmacy or Pharmaceutical Engineering.
• Ability to work independently and in a collaborative team-oriented setting and be process-oriented.
• Must have demonstrated strong analytical and communication skills, both verbal and written.  
• Motivated to learn new environments and tools and to serve as the point of contact for automation support.
• Have a detail-oriented personality.
• Ability to work collaboratively with other groups of scientists, developers, and technology transfer
• 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 about 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.

Who We Are

BPI Labs LLC is a specialty niche pharmaceutical company focused on the development and manufacturing of prescription products primarily in specialty-driven markets. BPI Labs focuses on difficult and challenging-to-manufacture drugs that may require dedicated environments as well as specialized intellectual property and/or equipment. From the early stages of development to commercial manufacturing and packaging, BPI Labs is your full-service provider.

Process of Hire:

Step-1: Review candidate profiles.

Step-2: Conduct written and/or verbal interviews.

Step-3: Offer extended and new hire/onboarding process begins.