Division Overview Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010) Job Overview Must have a strong HPLC and GC background. Mass spec and wet chemistry method experience is a plus. Responsibilities Capable of troubleshooting and validating test methods for complex formulations, especially inhalation products. Capable of developing methods with some support and guidance. Strong GC method development skills are required. Analytical experience with small molecule based formulations is preferred. Experience with common analytical instruments and familiarity with Metered Dosage Inhaler (MDI) testing is preferred. DUTIES & ESSENTIAL JOB FUNCTIONS Will support formulation development work by developing (with some guidance and support) and validating suitable analytical test methods, with a focus on GC methods. Will perform hands-on lab work and may coordinate work with junior level analytical staff. Need to provide routine characterization of the R&D formulations and should provide analytical support for studies necessary for chemistry and manufacturing controls. In addition, should be capable of troubleshooting methods and work with formulation scientists in developing assay methods (active and critical excipients), fast LC methods for DDU and APSD analytical finish, and transferring methods to the quality control (QC) laboratory. Must be able to draft test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP. Ability to guide junior level analytical scientists and chemists is preferred and should work closely with formulation scientists. Good oral and written communication skill and working in a team environment OTHER FUNCTIONS AND RESPONSIBILITIES Troubleshoot equipment problem and work with instrument manufacturer to resolve issues. Coordinate equipment qualification and calibration. Organize and maintain laboratory for efficient operation. Qualifications - Skills & Requirements • BS with 5+ years of experience (pharmaceuticals or related) or MS in Science with 3+ years of experience (pharmaceuticals or related) • Experience in test method validation • Experience with HPLC and GC, including strong GC MD skills • Must be able to perform laboratories duties that require standing for up to 90% of the work day, lifting containers containing up to 4+L of liquids and fine motor skills for conducting laboratory experiments (including weighing and pipetting). • Experience with test method development • Experience with MDI product testing • Experience developing generic products, including inhalation products • Familiarity with cGMP regulations, FDA guidance documents and QbD • Able to wear a respirator. Education & Experience Strong HPLC experience is a plus. Physical Requirements LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. • Must practice good personal hygiene • Must be able to lift up to 25 lbs. • Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. • Position requires working in the laboratory as well as sitting Additional Physical Requirements Job requires you to worker to reach or work above the shoulder Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment. We Are An Equal Opportunity Employer Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.