Aurobindo Pharma USA, Inc.

MANAGER/DIRECTOR, INHALATION R&D

Job Locations US-NC-Durham
ID
2021-2678
Category
R&D NC
Type
Aurobindo Pharma - NC

Division Overview

aurobindo Logo

 

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 Manager or Director will lead a team developing generic metered dose inhalers (MDIs).  Responsibilities include reverse engineering, device and formulation development, process development and scale-up, and generation of documents for regulatory filings.

Responsibilities

  • Lead a team of 4+ scientists and engineers
  • Develop generic MDIs
    • Reverse engineering of marketed products
    • Formulation and device development
    • Process development and optimization (pilot to exhibit scale)
    • Preparation of documentation for ANDA filing
  • Contribute to a cross-functional team to meet scientific, quality, and regulatory requirements for ANDA filing

Qualifications - Skills & Requirements

  • MDI formulation and process
  • Statistical design of experiments
  • Fine particle generation and characterization
  • Aerosol testing
  • Regulatory knowledge of the MDI space (e.g. Guidance Document familiarity)
  • Team leadership
  • Written and oral communication skills
  • Timeline and organizational skills

Education & Experience

  • Manager (2+ years) or Director (5+ years)
  • PhD preferred (chemistry, pharmaceutical science, chemical engineering, or related field)
  • Experience in MDI product development

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

Blood/Fluid Exposure Risk

Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.

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