Aurobindo Pharma USA, Inc. ยท 4 months ago
Analytical Scientist R&D
Durham, North Carolina
Full-time
Onsite
Mid Level
$68K/yr - $78K/yr
3+ years expAurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals. The Analytical Scientist R&D will support formulation development by developing and validating analytical test methods, focusing on GC methods, and providing analytical support for R&D formulations.
BiotechnologyPharmaceutical
Responsibilities
Capable of troubleshooting and validating test methods for complex formulations, especially inhalation products
Capable of developing methods with some support and guidance
Strong GC method development skills are required
Analytical experience with small molecule based formulations is preferred
Experience with common analytical instruments and familiarity with Metered Dosage Inhaler (MDI) testing is preferred
Will support formulation development work by developing (with some guidance and support) and validating suitable analytical test methods, with a focus on GC methods
Will perform hands-on lab work and may coordinate work with junior level analytical staff
Need to provide routine characterization of the R&D formulations and should provide analytical support for studies necessary for chemistry and manufacturing controls
In addition, should be capable of troubleshooting methods and work with formulation scientists in developing assay methods (active and critical excipients), fast LC methods for DDU and APSD analytical finish, and transferring methods to the quality control (QC) laboratory
Must be able to draft test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP
Ability to guide junior level analytical scientists and chemists is preferred and should work closely with formulation scientists
Good oral and written communication skill and working in a team environment
Troubleshoot equipment problem and work with instrument manufacturer to resolve issues
Coordinate equipment qualification and calibration
Organize and maintain laboratory for efficient operation
Qualification
Required
BS with 5+ years of experience (pharmaceuticals or related) or MS in Science with 3+ years of experience (pharmaceuticals or related)
Experience in test method validation
Experience with HPLC and GC, including strong GC MD skills
Must be able to perform laboratories 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 weighing and pipetting)
Experience with test method development
Experience with MDI product testing
Experience developing generic products, including inhalation products
Familiarity with cGMP regulations, FDA guidance documents and QbD
Able to wear a respirator
Preferred
Strong HPLC experience is a plus
Analytical experience with small molecule based formulations is preferred
Experience with common analytical instruments and familiarity with Metered Dosage Inhaler (MDI) testing is preferred
Ability to guide junior level analytical scientists and chemists is preferred
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
Company data provided by crunchbase