Principal Scientist, AR&D

**US CANDIDATES ONLY**

Granules Pharmaceuticals, Inc. is seeking a seasoned individual to join our Analytical R&D team as a Principal Scientist at our Chantilly, VA site!

• With minimal supervision, scientifically perform the analytical method development for dissolution, assay, related compounds, residual solvent test of raw material, excipients and finished products.
• Perform the analytical method validation for dissolution, preservative assay, particle size, assay, and related compounds of finished products using sophisticated instrumentation such as HPLC, GC, UV-Vis, FTIR, dissolution apparatus, particle size analyzer (Malvern) etc.
• Draft the analytical method validation protocols and reports
• Performs testing of pharmaceutical raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning verification/validation samples, and stability samples to support the 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 as 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.

Required Experience & Education

• Ph.D in Analytical chemistry, Pharmaceutical Sciences, or related field with 7+ years of expereince in analtyical development within OSD Pharmaceutical manufacturing industry OR;
• M.S. in Analytical chemistry, Pharmaceutical Sciences, or related field with 12+ years of experience in analytical development within OSD Pharmaceutical manufacturing industry

Required Knowledge, Skills & Abilities:

• Strong background and hands-on experience in Dissolution, UPLC, IC, HPLC, GC, UV, FTIR, Malvern particle sizer and other laboratory instruments.
• Experience with a wide variety of software and information systems (e.g. Empower, Microsoft word and Excel).
• Scientifically develop analytical methods and validation under cGMP environment and experience in instrument troubleshooting
• Demonstrate excellent scientific leadership.
• Ability to deliver complex objectives under challenging timelines in a rapidly changing environment.
• Demonstrate effective multitasking, prioritization and problem-solving skills in the planning and execution of experiments.
• Ability to work in a team environment with cross-functional interactions.
• Excellent verbal and written communication skills and the ability to write and review technical reports.
• Proficient in documentation as per Good Documentation Practice.

Physical Requirements/Working Environment

• 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).

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.