Analytical Chemist

Analytical Chemist

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

• The Analytical R&D Chemist will support the Formulations Group in developing and validating analytical methods for raw materials and finished products, reverse engineering of formulation components and analysis of stability samples.

• The position will be primarily laboratory based and requires a strong background in chromatography and preferably in semi-solid dosage forms

• The candidate will have a proven track record developing and validating GMP-compliant HPLC & GC methods to assess drug substance and product stability, have experience diagnosing and troubleshooting HPLC instrumentation

• The scientist will routinely interact with other laboratory personnel, and will interact with vendors, customers, and business partners as necessary

• Prepares technical documents, including method development/validation protocols and reports, analytical test procedures, technical reports, change controls to support FDA submissions

• Executes method development and validation protocols for finished products

• Reverse engineer formulation components using sample preparation and analytical procedures.

• Evaluates the chemical and physical attributes of finished products such as pH, viscosity, water content, assay and content uniformity

• Maintain the analytical lab including calibration, performance maintenance and log books

• Ability to analyze, interpret and troubleshoot data

• Follow Company's SOPs and ensure cGMP compliance

• Assists in the investigation of OOS/QR and OOT data and assist in writing investigative documents

• Responsible for maintaining laboratory housekeeping, cleanliness of laboratory equipment and workbenches, and other general lab responsibilities as assigned by supervisor

• Might require to work on extended hours on an as-needed basis

Qualifications

• B.S./M.S. in chemistry, pharmacy or related discipline with 2+ years related experience

• Previous experience in a cGMP laboratory setting

• Ability to handle multiple projects, efficiently and timely manner

• Knowledge of the generic industry, including ANDA submission

• Experience with topical and ophthalmic products is preferred

• Ability to work in a dynamic working environment