Granules India Limited · 3 months ago
Senior Scientist, Analytical R&D
Chantilly,VA,US
Full-time
Onsite
Mid, Senior Level
4+ years expGranules Pharmaceuticals, Inc. is seeking a detail-oriented and scientifically driven Sr. Scientist to join their team in the area of Analytical Method Development and Validation. The role involves developing and validating analytical methods and ensuring compliance with regulatory standards, while also providing training and support to junior team members.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
With minimal supervision, perform the analytical method development and method validation for dissolution, assay, and related compounds of raw material and finished products
Develops and validates methods to determine purity, potency, identity, residuals, and characterization of peptide products
Ability to individually work on development and validation for Reversed-Phase, Ion Exchange, and Size Exclusion chromatography using UPLC/HPLC/MS
Draft the analytical method validation protocols and reports
Performs testing pharmaceutical raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning verification/validation samples, and stability samples to support formulation development
Responsible for the timely and accurate execution of lab analysis
Independently compile the analytical data, make sound judgment of the data and interpret the data, and notify the results to manager/Director
Maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs
Maintain laboratory notebooks and records of all the raw data as per Good Documentation Practices
Assists with training other junior members of the analytical development team as needed
Maintain individual training records
Follow safety procedures and practices
Maintain a clean, orderly work environment
Works with computer-controlled equipment and processes
Performs other work-related duties as assigned
Perform in-vitro dissolution testing for in-process, finished product and stability samples
Execute method transfer activities for raw materials and finished dosage forms
Ensures compliance with SOPs, policies and procedures required by the Company and regulatory agencies
Document experiments accurately and complete all associated documents (Instrument, Standard and Column usage logbooks) in compliance with internal SOPs and FDA guidelines
Evaluate test results against standards and timely reporting of any deviations, OOS, OOT and atypical results to the supervisor/department head
Other duties assigned by management based on requirements
Assign daily work schedule in timely manner
Provide Suggestions in method Development and validation
Interpret and review generated results
Provide assistance in professional development
Qualification
Required
Bachelor's degree in Analytical Chemistry or Chemistry or related field with 4+ years or MS/PhD with 2+ years of GMP and GLP-related pharmaceutical industry experience in Peptide and small molecule solid oral formulation analytical development
Hands-on experience in Dissolution, HPLC, LC-MSGC, UV, FTIR, and other laboratory instruments
Strong knowledge in analytical method development and validation under cGMP environment and experience in problem-solving skills and instrument troubleshooting
Good oral and written communication skills and the ability to write and review technical report
Proven Knowledge of the major analytical techniques and operation of instruments such as HPLC, GC, dissolution, FT-IR, UV-VIS Spectrophotometer, Particle size analysis (Malvern Mastersizer, Sonic sifting and Sieve shaker), Karl Fisher Instrument, Potentiometric Titration, Density meter, pH meter, Melting point apparatus, Analytical Balances, Viscometer
Proficient in documentation as per Good Documentation Practice
Computer skills including Microsoft and Excel
Excellent verbal and written communication and skills
Experience with a wide variety of software and information systems (e.g. Empower, Microsoft word and Excel)
Knowledge of Good Manufacturing Practices (cGMP)
Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE
Vision - ability to see details at close range (within a few feet of the observer)
Company
Granules India Limited
Granules India Ltd. is a fully integrated pharmaceutical manufacturer.
5001-10000 employees
H1B Sponsorship
Granules India Limited 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 (6)
2024 (7)
2023 (5)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
MAPE Advisory Group
2005-09-01Post Ipo Equity
2005-06-20IPO
Recent News
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