SCIENTIST

Overview

Must have strong background in method development and validation using UPLC, LCMS and GC. GCMS is a plus. Independent worker is prefered.

Responsibilities

Capable of troubleshooting and validating test methods for topical formulations. Ability to perform stability, in-process and finished product testing for R&D and release testing.

Capable of developing methods with some guidance and experience with common analytical instruments. Ability to guide junior level analytical scientists and chemists is preferred and should work closely with formulation scientists.

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 HPLC and GC methods.

Will perform hands-on lab work and 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), and transferring methods to the quality control (QC) laboratory.

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).
• Good oral and written communication skill and working in a team environment.
• Strong HPLC and GC method development skills are required.
• Must be able to draft test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP.
• Experience with test method development
• Experience with Empower 3 and electronic notebook
• Experience developing generic products, including inhalation products
• Familiarity with cGMP regulations, FDA guidance documents and QbD

Education & Experience

MS or PhD degree in Chemisty perferred.

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

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.

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