Senior Analytical R&D Chemist

compensation: Based on experience
employment type: full-time


The Senior Analytical Chemist will provide technical guidance, solve problems, and make a hands-on contribution from R&D method development through GLP/GMP method validation and transfer the method to our own manufacture facility.  This position is a chemist with expertise and demonstrated abilities in the development and application of analytical methods.  The majority of the work is laboratory based and the ability to perform analytical tests within the laboratory and interpret and communicate the results is critical.  The Senior Analytical Chemist will work independently, manage their own projects, and provide guidance and training for junior analytical chemists.


Responsibilities:

  • Develop, evaluate, troubleshoot, validate, and transfer analytical methods
  • Author, review, and execute method validation and transfer protocols and reports
  • Design and execute forced degradation, excipient compatibility, cleaning validation, and stability experiments
  • Evaluate and interpret analytical data and communicate results to management and functional teams.
  • Provide scientific guidance and training for junior analytical chemists
  • Write and review SOPs
  • Manage analytical projects. Establish schedules, define priorities, and direct activities of other scientists and non-scientists as well as provide training and development for others.


Qualifications:

  • Master degree in Chemistry, Pharmacy or related areas.
  • Minimum of 2 years of pharmaceutical laboratory experience in analytical R&D
  • Extensive knowledge of cGMPs, GLPs, and FDA/ICH guidelines and their application to drug development
  • Technical expertise in developing and running analytical methods using common quantitative techniques including HPLC, UV/Vis, GC, and wet chemistry. 
  • Experience with ANDA analytical method development, in-vitro release testing, such as USP dissolution, HPLC Assay and Degradation Product, Forced stability testing, and
  • Experience with analytical method development of a broad range of dosage forms such as tables, capsules, device/implants, suspensions, lyophilized products, and novel formulation types is preferred
  • Excellent problem solving skills
  • The ability to manage multiple projects simultaneously, set priorities, and meet key deadlines
  • Exceptional written and verbal communication
  • Capable of working independently


Interested applicants should send a resume and cover letter to info@pharmulalabs.com