Senior Formulation Scientist

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

This is a Senior Formulation Scientist role in Generic Pharma, product development with 3 – 5 years industrial experience. This role is very hands-on. Must have experience in development to large scale submission batch manufacture.

Responsibilities

Senior Scientist with previous industrial experience developing and filing generic drug dosage forms (orals/liquids) Ability to develop the product using FBD, Compression and Encapsulation Ability to perform extensive Literature Search on assigned Projects. Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product development Experience working with projects from bench-top stage to large scale manufacture of submission batches Should have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up

Qualifications - Skills & Requirements

3-5 years of Senior Scientist Formulation development and process development Experience in the generic drug industry with ANDA filing experience. Must have ability to work in a team with excellent spoken and written communication skills Must be legally able to work in the US without requiring sponsorship Must have reliable transportation and must be able to work overtime when required

Education & Experience

MS or PhD in Pharmaceutics or related field Experience in working with DEA controlled drug substances and relevant regulations. Experience in developing controlled-release product using Fluid Bed Processor (Wurster coating) technology. Compensation Min USD $70,000.00/Yr. Max USD $80,000.00/Yr. Benefits Annual bonus

• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through CIGNA
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability
• Long-Term Disability (LTD), State (short term) disability – where applicable
• FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off - Paid vacation, PTO, ten paid Holidays annually
  
  

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to:

• Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
• Specific vision abilities required by this job include close vision requirements due to computer work
• Light to moderate lifting is required
• Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
• Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 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., 3-5 years of Senior Scientist Formulation development and process development Experience in the generic drug industry with ANDA filing experience. Must have ability to work in a team with excellent spoken and written communication skills Must be legally able to work in the US without requiring sponsorship Must have reliable transportation and must be able to work overtime when required, Senior Scientist with previous industrial experience developing and filing generic drug dosage forms (orals/liquids) Ability to develop the product using FBD, Compression and Encapsulation Ability to perform extensive Literature Search on assigned Projects. Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product development Experience working with projects from bench-top stage to large scale manufacture of submission batches Should have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up