Scientist, Analytical Research and Development

Aurobindo Pharma USA, Inc.•Durham, NC

23h•Onsite

About The Position

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) This position requires an experienced analytical chemist who can work both independently as well as in a group setting. The ideal candidate will have experience in GMP requirements as well as general method development and instrument trouble shooting. Candidate should have the heart of a teacher given this is a more advanced role and the team is comprised of chemist at various stages in their careers.

Requirements

Experience in test method validation
Empower software experience.
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 with HPLC and GC instrument trouble shooting
Must be comfortable and confident when teaching less experienced chemists.
Experience developing generic products, including inhalation products
Familiarity with cGMP regulations, FDA guidance documents and Q2b
Able to wear a respirator.
Ability to multi-task is essential.

Nice To Haves

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 and should work closely with formulation scientists.

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.
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.

Benefits

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, Holiday