Aurobindo Pharma USA, Inc. · 5 months ago
Scientist I Inhalation Research and Development
Durham, North Carolina
Full-time
Onsite
Entry, Mid Level
$75K/yr - $80K/yr
2+ years expAurobindo Pharma USA, Inc. is a leading generic pharmaceutical manufacturer and distributor. The Scientist I is responsible for the development of metered dose inhaler (MDI) products, including formulation, device, and process development, while ensuring compliance with FDA and ICH guidelines.
BiotechnologyPharmaceutical
Responsibilities
Generates high quality documents including process documentation, operating instructions, protocols, and reports. Plan and coordinate team effort to deliver documentation packages on time and with high quality
Analyzes and resolves outstanding issues in early to late stage MDI product development. Identifies and fills scientific and regulatory gaps
Applies sound knowledge in product specific guidelines and relevant regulatory monographs for metered dose inhaler (MDI) products
Identifies opportunities and initiates and follow through scientific investigations to support key decision making in product development
Selects components (valves, cans, actuators, dose counters, overwraps) for MDI development
Develops, troubleshoots, and optimizes MDI processes from lab to pilot scale. Assists in scale up and transfer of processes from pilot to exhibit and commercial scale
Maintains a state of readiness of the MDI process equipment by performing preventive maintenance, calibration or functional modification as necessary
Characterizes active pharmaceutical ingredients (APIs) for respiratory products using techniques such as particle size by laser diffraction, Karl Fischer (KF) moisture analysis, thermogravimetric analysis (TGA), and microcalorimetry
Additional tasks as required
Qualification
Required
Familiarity with health and safety regulations and cGMP
Possesses strong interpersonal / oral and written communication skills and ability to work in a team environment
Experience in MDI processing from R&D / pilot scale
Possesses strong understanding of fundamentals of inhalation products in general and MDI products in particular
Possesses strong understanding of ANDA product development program flows and able to generate high quality documentations to support ANDA filing
Excellent documentation generating skills in a GMP environment
Sound knowledge with product specific guidelines and relevant regulatory monographs for MDI products
Education: BS degree in Chemistry, Engineering, Pharmaceutical Sciences, or related field with 8+ years' experience, MS with 4+ years' experience, or Ph.D. with 2+ years' experience
Preferred
Exhibit or commercial MDI process experience preferred
Experience in statistical design of experiments as applied to MDI formulation and processes is a plus
Experience in MDI processing from R&D to pilot scale
Benefits
Annual bonus
Medical and Rx Benefits: choice of four medical plans through Horizon. Rx is 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
Company
Aurobindo Pharma USA, Inc.
Aurobindo Pharma is a pharmaceuticals company offering generic pharmaceuticals.
501-1000 employees
H1B Sponsorship
Aurobindo Pharma USA, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2023 (4)
2022 (10)
2021 (9)
2020 (10)
Funding
Current Stage
Late StageLeadership Team
Swami Sambamurty Iyer
Chief Executive Officer
Recent News
2025-06-28
Business Standard India
2024-11-25
2024-11-24
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