Analytical Chemist

  Job Summary Under the leadership of Quality Control Manager, the Analytical Chemist is responsible for performing testing related to incoming APIs, excipients and finished goods samples by developing test methods using UPLC potency assays for ophthalmic drug products. The methods will be developed as stability-indicating, and, following validation, will be utilized for stability and QC testing. The analyst must be familiar with the workings of a GMP chemistry lab, equipment and documentation requirements, including following standard operating procedures, using proper documentation, performing forced degradation, method validation, preparing samples and analyzing results. Position Responsibilities:  Under the leadership of Quality Control Manager, define the requirements to set-up new analytical instrumentation laboratory. This will include but not be limited to, design and development of laboratory space, identifying instrumentation requirements and methods. Responsible for setting up quality systems required for testing, APIs, excipients, finished goods and stability samples. Conduct investigational analysis on non-conforming materials and collaborate with supply chain for immediate resolution. Define strategies to address quality-related objectives and will recommend the methods and specifications used to monitor pharmaceutical materials and/or the formulated product. Partner with external testing laboratory to transfer testing methods in-house. Establish, develop, and/or optimize analytical methodology to test finished dosage R&D drug products and commercial products across multiple dosage forms.  Draft analytical development reports and other technical documents related to analytical development activities. Perform a variety of routine laboratory procedures utilizing analytical instruments such as UPLC/HPLC in support of new and improved product development work. A thorough understanding and working knowledge of industry guidance, separation sciences, spectroscopy and a variety of hands-on analytical techniques, e.g. HPLC, Dissolution, Karl Fischer, FTIR, UV Spectroscopy, and particle size analysis. Experience Requirements and Qualifications: BS or BA degree in Chemistry (or equivalent degree in a relevant Pharmaceutical Science) with ideally eight years of professional experience in pharmaceutical analytical chemistry; Must have experience with establishing new laboratory and quality systems; Strong interpersonal skills, including the ability to effectively and efficiently communicate in verbal and written forms at any level within the organization and interact effectively with internal and external customers and business professionals. Perform other duties, as assigned. Ability to identify and implement process improvements, implement creative or novel solutions under minimal supervision. Commitment and drive to improve manufacturing operations Position Type and Expected Hours of Work  This is a full-time position working Monday through Friday in Ledgewood, NJ. Occasional overtime and evening hours and/or weekends may be required as per business needs. Travel Requirements 10% of travel between Imprimis facilities is required for this position.
Salary Range: NA
Minimum Qualification
8 - 10 years

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