1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456

Analytical Manager

Career Opportunities



We are looking for talented and dedicated individuals for our team. If great ideas inspire you, perhaps there’s a place for you at PuraCap. You’ll enjoy a challenging environment, terrific colleagues and all the opportunities your drive and initiative can handle.


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Title: Analytical Manager
Position Type: Full time
Reporting line: Site Director of R&D
Effective Date: Immediately


Position Summary

PuraCap Pharmaceuticals is an exciting, growing company with an established footprint in the manufacture and distribution of OTC pharmaceutical products as well as topical prescription medications.  Successful candidate will be responsible for carrying out analytical method development and validation activities and testing for oral solid dosage formulations (capsule, tablet, softgel etc.)

A.   Major Duties / Responsibilities:

  • Developing analytical methods and performing testing using a variety of technologies including HPLC, GC, Dissolution, UV, etc.
  • Provide training to individuals in junior positions.
  • Maintain proper instrument calibration status.
  • Actively participate in the preparation of regulatory submission dossier with focus on CMC module and analytical package.
  • Independently solves analytical problems and develops solutions.
  • Perform other duties as assigned.
  • Planning and executing projects in support of departmental needs.
  • Product deformulation and product development, failure analysis and problem solving, impurity identification, structural characterization, and analytical testing in support of industrial problem solving and litigation.
  • Generating various analytical protocols, development/validation/testing reports and final methods.
  • Ensuring compliance with government rules and regulations (FDA, cGMP, ICH, OSHA, etc.)


Education:  Masters of Science in Chemistry or a pharmaceutical –related science; Ph.D. degree in Chemistry or Pharmaceutics is plus.
Experience:Additional Skills / Knowledge: Minimum five years of relevant experience is required

  • Strong hands-on experience in analytical instruments, such as HPLC, dissolution, GC, Karl Fisher, etc.
  • Working experience with analytical method development and validation on API and finish product
  • Excellent team and interpersonal skills
  • Ability to interact successfully with multiple cultures
  • Good knowledge of cGMP, ICH, and other FDA or international guidance and regulations. Prior working experience in ANDA/ NDA submission package preparation is a big plus
  • Demonstrate compliance with procedures and policies
  • Strong written and verbal communication skills
  • Strong attention to detail
  • Willingness to work flexible hours



  • Laboratory and office environment
  • Ability to stand/walk on hard surfaces for extended periods of time
  • Up to 20% domestic and international traveling

PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.


If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com