ARD Senior Scientist

Research & Development Carmel, New York


Description

Position Summary:

Develop, revise and validate analytical methods in support of product development and IND/NDA/ANDA filings. Performing of analytical testing as required. Organize/Manage individual Project.

Reporting:

ARD Manager/Supervisor/Team Leader.

Essential Duties & Responsibilities:            

  • Conduct literature searches and be the custodian of the assigned projects. Conduct advanced analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications. Conduct analytical method validation and method transfer.
  • Develop and validate analytical test methods for assay, impurities/degradation products, preservatives and leachable in drug products according to ICH/FDA/USP requirements.
  • Develop and validate test methods for residual solvents in drug substances/excipients according to ICH/FDA/USP requirements.
  • Prepare timelines for assigned projects and issue regular update reports on progress of projects.
  • Provide analytical support to Product Development, QC, QA and Regulatory departments as needed. Perform trouble-shooting and investigations under the direction of management. Perform structure elucidation of unknown impurities/degradation products when necessary.
  • Conduct reverse engineering and problem solving of analytical methods and product related issues.
  • Perform analytical testing on R&D batches, associated stability studies and Cleaning Validation samples. Generate the relevant analysis reports.
  • Perform testing to qualify raw materials vendors and assist in establishing product specifications.
  • Responsible for developing and executing analytical protocols (e.g. Method validation) and draft related testing methods and validation reports
  • Develop test method for evaluating both the physical and chemical aspects of new pharmaceutical products.
  • Maintain good documentation practices and proper laboratory notebooks and prepare ARD reports. Review other scientists’ notebooks when required.
  • Prepare/review test methods, method validation protocols and reports. Recommend and draft SOPs for general laboratory procedures.
  • Prepare/review Modules and QOS for ANDA/NDA submission
  • Train other laboratory scientists on analytical instrumentation and methods.
  • Multi-task by working on several simultaneous projects. Provide regular update reports on progress of projects.
  • Introduce and evaluate new technologies/instrumentation and assist the department head with the introduction of new technologies and instrumentation.
  • Comply with all relevant regulatory requirements.
  • Other projects and duties as required or assigned.

Position Requirements

Education:         

  • Bachelor’s degree in Chemistry or related scientific discipline
  • Master’s Degree
  • PhD Degree

 Experience Required:    

  • 10+ years in the pharmaceutical industry with BS/BA
  • 8+ years in the pharmaceutical industry with MS
  • 3-5 years in the pharmaceutical industry with PhD

 Competencies:  Competency                     Proficiency Level

  • Job Knowledge                                   Advanced
  • Excellence in Execution                      Advanced
  • Communication/Teamwork                 Intermediate
  • Language                                            Advanced
  • Math                                                    Advanced
  • Reasoning                                           Advanced
  • Internal/External Customer Focus      Intermediate     
  • Management/Leadership                    Intermediate            

Instrumentation/Techniques:

  • Assay, Related substances, Residual Solvents tests
  • Karl Fischer, Melting point apparatus, Viscometer
  • UV/Vis spectrophotometer, IR spectroscopy
  • NIR, FT-IR
  • Wet chemistry techniques
  • USP Dissolution apparatus I, II, III, IV, rotating bottle apparatus and Franz Cell apparatus
  • Bulk and Tap Density apparatus
  • HPLC/UPLC with UV variable wavelength, PDA, RI, Fluorescence, ELSD, CAD detectors and LC/MS
  • GC and GC/MS
  • Optical and specific rotation apparatus
  • Particle size analyzers
  • TGA, DSC and Powder flow-meter, Sorption/Desorption, SEM and Optical Microscopy
  • ICP/OES and ICP/MS
  • XRD, NMR

Performance:   

  • Maintains confidentiality
  • Comply with all cGMP requirements and Company policies, procedures, rules and regulations
  • Possesses sound analytical problem-solving and documentation skills
  • Communicates effectively. Writes and speaks clearly and concisely
  • Demonstrates ability to prioritize conflicting demands
  • Executes assigned tasks within established schedule
  • Develop and maintain expertise in chemistry/pharmaceutics through continuing professional education and training
  • Knowledgeable with MS Office