AR&D Scientist III

Research & Development Philadelphia, Pennsylvania


Description

We are seeking a detail oriented person to join our Analytical R&D Department as a Scientist III at our Torresdale Avenue facility. We are looking for someone ready to independently perform research and development analytical laboratory testing as well as train and assist in laboratory operations and planning.

 
Position Summary:

Responsible for supporting product development trial samples testing and method development/validation for primarily stability-indicating analytical methods that are applicable to specific pharmaceutical products.

Perform routine wet chemical and instrumental analysis on raw materials and finished products. Develop, revise and validate analytical methods. Accurately compiles and reports data.  Gather, compile and compose documents needed for regulatory submissions.

Develop, revise and validate analytical methods in support of product development and IND/NDA/ANDA filings.

Reporting:

ARD Manager/Team Leader.

Essential Duties & Responsibilities           

  • Conduct literature searches for assigned projects. Conduct 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, dissolution, impurities/degradation products, preservatives and leachables 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.
  • Perform complex routine and non-routine physical and chemical tests on raw materials, API’s, in-process and finished products and test R&D trial batches and associated stability studies and generate analysis report.
  • Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report.
  • Responsible for developing and executing analytical protocols (e.g. Method validation) and drafting the related test methods and validation reports.
  • Develop test methods 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.
  • Recommend and draft SOPs for general laboratory procedures.
  • Prepare/review Modules and QOS for ANDA/NDA submission
  • Assist junior scientists in planning and executing analytical projects.
  • Provide regular update reports on progress of projects.
  • Multi-task by working on several simultaneous projects. Develop project timelines.  
  • Perform other duties as assigned.
  • Perform trouble-shooting and investigations under the direction of management.
  • 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 is a plus but not essential
  • PhD is a plus but not essential

Experience Required:    

  • 5-8 years of experience in the pharmaceutical industry with BS
  • 3-6 years with MS
  • At least 2 years with PhD

Competencies:   Competency              Proficiency Level

  • Job Knowledge                                  Intermediate
  • Excellence in Execution                    Intermediate
  • Communication/Teamwork               Intermediate
  • 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 and CAD detectors
  • GC and GC/MS
  • Optical and specific rotation apparatus
  • Particle size analyzers
  • TGA, DSC and Powder flow meter

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