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.

 

Essential Duties and responsibilities are not limited to the following:

 

  • Perform complex, routine, and non-routine physical and chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process and finished products, using various wet chemical, physical and instrumental techniques.
  • Perform literature searches, obtain and review scientific literature and vendor technical packages, and prepare reports as assigned.
  • Develop and validate analytical test methods in drug products according to ICH/FDA/USP requirements
  • 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
  • Multi-task by working on several simultaneous projects. Provide regular update reports on progress of projects.
  • Transfer procedures to other groups and perform training as assigned.
  • Independently plan and execute testing to meet established deadlines.  Actively participate in planning and delegating testing to meet deadlines.
  • Introduce and conduct training on new technology, techniques, and instrumentation.  Monitor ongoing training needs and make recommendations to management.
  • Record data and results as specified in documentation procedures.
  • Review and approve data and results as assigned.
  • Initiate, author and revise test procedures, SOPs, technical reports, validation protocols and reports, and other documents.
  • Keep abreast of all relevant regulatory requirements and assist in ensuring compliance.
  • Supervise other staff as assigned.

 

Educational Requirements and/or Work Experience

  • 4-8 years with BS/BA in the pharmaceutical industry
  • 3+ years with MS in the pharmaceutical industry
  • In-depth knowledge of cGMPs and other regulatory requirements and a basic understanding of pharmaceutical development and manufacturing.

           

Skills Requirements

  • Thorough knowledge of laboratory test procedures and instrumentation, especially HPLC; USP/NF methodology; relevant regulatory requirements.  In-depth knowledge of scientific concepts.
  • Extensive knowledge of method development and validation.
  • Ability to read and interpret test procedures, manuals, technical documents or instructions in mathematical or diagram form, SOPs and governmental regulations.  Ability to summarize and explain such documents to more junior and senior staff as well as to non-scientists.
  • Ability to apply concepts such as fractions, percentages, ratios, proportions, and statistics to practical situations. Ability to apply mathematical concepts of experimental design and data analysis.
  • Ability to perform mathematical calculations used for assigned testing and to assist more junior staff in performing calculations. 
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to report data and observations accurately, both in writing and verbally.

 

We offer a comprehensive benefit package, including medical, vision, dental, and prescription, immediate eligibility in the 401(k) plan with generous company match, Employee Stock Purchase Plan, and tuition reimbursement.  Candidates must be able to pass a company paid background check and post-offer drug screen.  Lannett Company, Inc. is an Equal Opportunity Employer.