Scientist, Inhalation Reserach and Development-NC

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

Capable of performing characterization studies for inhalation products, particularly for metered dose inhalers (MDIs). Experience in developing, validating, and/or executing test methods for the characterization of MDIs is preferred; GMP experience with other dosage forms may be considered. Should be able to write SOPs, test methods, protocols and reports as per FDA and ICH guidelines and should follow cGMP guidelines.

Responsibilities

• Assists in the development of study designs and plans for study types ranging from reverse engineering to method development/validation to product characterization..
• Drafts protocols and performs experiments independently with some guidance from Director.
• Organizes and presents data to support and document product development decisions.
• Leads investigations to support product and method optimization.
• Supports investigations in product release and exhibit stability studies and devises/supports corrective actions.
• Performs technical review of experiments and documents.
• Mentors junior analysts and leads/organizes general training and technique training
• Works with Director, formulations team, and regulatory team to draft sections and present data for tech transfer and submission documents.
• Leads or performs in at least one lab maintenance activity: instrument owner, software system owner, metrology, hazardous waste management, software validation, ELN template development/validation, instrument qualification, etc.
• Writes SOPs based on industry guidance and trends. Revises existing SOPs to streamline the process and keep up with changes in industry best practices.
• Writes and revises test methods to ensure efficiency, robustness, clarity, and implementation of best practices.
• Supports the review, training, and tech transfer of methods to commercial.
• Will perform inhalation testing for inhalation products, particularly MDIs. Will perform MDI characterization methods including total can assay, aerodynamic particle size by next generation impactor, delivered dose through container life, particle size by laser diffraction, Karl Fischer moisture, spray pattern & plume geometry, foreign particulate matter, and microscopic evaluation.
• Will work with analytical scientists to support the development and validation of sample collection methods.
• Will troubleshoot methods and conducting laboratory investigations. Prepare SOPs, protocols, and reports. Performs studies according to the stage-appropriate quality system to meet product development timelines.
• Troubleshoots equipment and coordinates equipment qualification and calibration.
• Maintains a clean and safe working environment.
• May assist in MDI formulation and filling.

Qualifications - Skills & Requirements

• Experience with developing, validating, or executing MDI characterization methods
• Must be able to perform laboratory 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 product actuation, weighing, and pipetting).
• Must possess excellent oral and written communication skills and be able to thrive in a team environment.
• cGMP pharmaceutical experience

Education & Experience

• BS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field pluse 8 years experience or MS with 6 years
• At least one year of experience in a GMP environment, with MDI product development reqired

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

No Additional 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.