Chemist A, R&D Orals

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

• The Chemist will work as a member of the Analytical R&D team to effectively plan and develop/validate new methods (for Assay, Dissolution, Residual solvents, Related compounds tests etc..) for oral solids and/or raw materials.
• The Chemist may execute 80% - 100% of their work at the bench level.

Responsibilities

• Hands on experience to Perform/develop assigned physical and chemical tests on raw materials and active pharmaceutical ingredients using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine instruments).
• Able to perform/develop assay, related compounds and dissolution testing on in-process, finished product and stability samples using various wet chemicals, physical and instrumental techniques (HPLC/UPLC, Dissolution, GC, UV-Vis, and other routine instruments).
• Perform analytical method validation for various tests including but not limited to assay, related compounds, dissolution, residual solvents and particle size by Malvern.
• Independently plan and execute testing to meet established timelines.
• Perform complicated testing with supervisory direction.
• Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
• Prepare and/or review Test Procedures, SOPs, Validation Protocols/Reports as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing tassigned activities.
• Review and prepare technical documents as required.

Qualifications - Skills & Requirements

• R&D/QC experience in the Generic Pharmaceutical industry, however R&D experience would be preferable.
• Proficient in common Microsoft office skills.
• Experience handling controlled substances within DEA requirements is preferable.
• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA/DEA regulations is preferable.
• Ability to learn quickly and decision-making skills.
• Good time management skills are required.
• Must be able to work in the US without requiring sponsorship

Education & Experience

• MS or PhD in Analytical Chemistry or related field
• Experience in working with DEA controlled drug substances and relevant regulations.

Compensation
Min

USD $60,000.00/Yr.
Max

USD $65,000.00/Yr.
Benefits

Annual Bonus, 401K and medical and dental/vision insurance
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 shoulderLifting 8+ Hours - 10-15 PoundsStanding 4-8 HoursWalking 5-8 Hours

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.