Career

Career

Sr. Analytical Scientist

Description:

Sr. Analytical Scientist will be required to develop analytical methods for various drug products and participate in the validation of these methods.  This position requires that the candidate be proficient and skilled in the art of all aspects of analytical research and development as they relate to method development, validation and transfer for pharmaceuticals intended for the branded and generic markets. The candidate must be must have a broad and far-reaching understanding of the chemical literature, including standard and novel methods and techniques such as HPLC, UPLC and GC.

Key Accountabilities:

  • Develop and validate methods to meet project milestone dates.
  • Reads and understands SOPs and follow policy, procedure and applicable FDA regulations, such as current Good Manufacturing Practices (cGMP), DEA compliance, quality standards and safety requirements.
  • Draft R&D SOPs to enhance the efficiency of the laboratory.
  • Maintain accurate and complete notebook records for all method validation and investigational studies in accordance with SOPs, cGMP, and current Good Documentation Practices (cGDP) requirements.  For all development work, utilize peer review to ensure accuracy and completeness.
  • Implement improvements to analytical test methods or to instrumentation.
  • Project Management       Ensure that analytical methods are developed and validated as efficiently as possible to ensure that business milestones are met.
  • Safety    Ensure testing is conducted in a safe manner including but not limited to the proper PPE and ventilation.  Any safety issue must be brought to the attention of the Supervisor or Manager ASAP.
  • Quality Write investigations as needed and work with Supervisor or Manager to resolve and close the investigations in a timely manner.

Education and Knowledge:

  • B.S. or M.S. degree in chemistry, biology or related field with 6-10 years of experience in the Pharmaceutical industry or a Ph.D. with 5+ years of experience.
  • Understanding of cGMPs and cGDPs.
  • Understanding of Regulatory requirements.
  • Understanding of Safety requirements.

Skills and Abilities:

  • Highly organized.
  • Flexible and able to work in a team environment.
  • Proficient with Microsoft programs such as word and excel.
  • Good communication skills.
  • Good written skills.
  • Proficient with a variety of analytical instrumentation.  Some examples are Waters HPLC, GC, Dissolution Baths and Titrators.

Physical Requirements:

  • Work in laboratory environment.
  • Ability to work on feet for an extended period of time.
  • Ability to move and lift up to 25 lbs.

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About Dharma Labs

Dharma Laboratories is global provider of product development services and has experience in developing Branded and Generic Product. We have

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Product Development We have extensive Product development expertise in Branded and generic product with  decades of drug pre-formulati

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