Essential Duties & Responsibilities Designs and formulates all facets of product development, from inception to scale-up Develops 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 Interfaces with Analytical Services for testing of excipient compatibility, raw material qualification, analysis, and drug substance and product stability Anticipates, recognizes, and resolves or escalates technical issues through use of technical resources including technical literature, technical experts and well formulated, logical experimentation Maintains and troubleshoots equipment as an instrument owner, where appropriate. Evaluates and interprets data and communicates results to management and functional teams Documents in laboratory notebooks and in-house reporting formats without error in a highly-regulated cGMP environment.
Required Education, Skills & Experience Minimum of a Bachelor’s degree in a related discipline &/or previous relevant experience in drug product formulation. Previous 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 Physiochemical understanding of formulation components and interactions & experience in physical characterization techniques Comfortable working within a regulated environment following QbD, cGMP and SOP protocols.
Considered a Plus Experience with a broad range of dosage forms such as tablets, capsules, device/implants, suspensions, lyophilized products, and novel formulation types Experience with multiple delivery forms (semisolids, solids, liquids, suspensions, including sterile and non-sterile) Experience with complex delivery forms (microparticles for controlled release, engineered particles, encapsulation, nanotechnology) Experience writing client reports Experience developing SOPs, IQ/OQ/PQ protocols, and other regulatory documentation
Lubrizol offers competitive benefits: Medical, Dental, Vision, 401(k), Age-Weighted Defined Contribution Plan…and so much more! Visit http://benefits.lubrizol.com to learn more.
Lubrizol Life Science Health's CDMO business is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown, Bethlehem and Easton. The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action. Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play. This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife. From the yearly Musikfest festival, to skiing in the Poconos, to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley.
Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law. Do You Need Assistance? Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process. You can either call 440-943-4200 and ask for Talent Acquisition or send an email to [email protected]. Please note that this phone line and email address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters.
Nearest Major Market: Allentown
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