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Formulation Scientist

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Date: Jan 13, 2021

Location: Bethlehem, PA, US, 18017

Company: Lubrizol Corporation

Particle Sciences, Inc. in Bethlehem, PA has an immediate opening for a Formulation Chemist.

Particle Sciences is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world’s largest pharmaceutical and biotech companies to small VC backed start-ups.  Particle Sciences has been part of Lubrizol Corporation’s Advanced Materials – Life Sciences division since January 2016.

As a member of the Particle Sciences, Inc. team you will be engaged in important, exciting, and socially relevant projects.  The formulation laboratories are a great place to work, and provide a fast-paced environment with a variety of responsibilities, technical challenges, and opportunities.

 Essential Duties and Responsibilities

  • Include design, formulation and all phases of product development from inception to scale-up
  • The successful candidate will have a strong physiochemical understanding of formulation components and interactions, and experience in physical characterization techniques
  • Experience with complex delivery forms is desired (microparticles for controlled release, engineered particles, encapsulation, nanotechnology)
  • Experience with multiple delivery forms is ideal (semisolids, solids, liquids, suspensions, including sterile and non-sterile)
  • You will be involved in the development of client projects from pre-formulation, formulation development and characterization, production of pre-clinical and clinical trial materials, scale-up, and technology transfer to client companies
  • Responsibilities include the ability to interface with Analytical Services for testing of excipient compatibility, raw material qualification, analysis, and drug substance and product stability
  • You must be comfortable working within a regulated environment following QbD, cGMP and SOP protocols.
  • Experience writing client reports, and developing SOPs, IQ/OQ/PQ protocols, and other regulatory documentation is desirable
  • Documenting in laboratory notebooks and in-house reporting formats without error in a highly regulated cGMP environment.
  • Evaluating/interpreting data and communicating results to management and functional teams
  • Anticipating, recognizing, and resolving or escalating simple and complex technical issues. This is accomplished through knowledge, use of technical resources including technical literature, technical experts and well formulated, logical experimentation
  • Maintaining and troubleshooting equipment as an instrument owner where appropriate

Knowledge, Skills and Abilities

  • The successful candidate should have a minimum of a BS/BA degree in a related discipline or previous relevant experience in drug product formulation.
  • Preferably at least 2 years of related experience in the pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)
  • Practical knowledge of cGMPs, GLP, and FDA/ICH guidelines and their application to drug development and release
  • Experience with a broad range of dosage forms such as tablets, capsules, device/implants, suspensions, lyophilized products, and novel formulation types is preferred
  • Proficiency with common PC based applications and specifically in the use of MS Office

Nearest Major Market: Allentown

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