Analytik NEWS
Online Laboratory Magazine
08/09/2022

Lab Analyst Pharma Services (m/f/d)

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Job Target:

  • Perform pharmaceutical analytical method development and validation services in our Westborough, MA / USA laboratory and on customers premises with the following focus: dissolution, assay, content uniformity, solubility studies, HPLC method transfer, and in-vivo/in-vitro correlation.
  • Propose and execute analytical product development projects in order to meet the needs of our existing clients and acquire new business.
  • Document activities in a compliant manner as well as creating and communicating project updates/summaries directly to the client.
  • Monitor changes in the regulatory environment, competition activity and developments at key customer sites.
  • Lead a team of Lab Analysts on a project basis.

Job Requirements:

  • BS, MS or Ph.D. in Analytical Chemistry or related discipline with a minimum of 3 years of relevant work
    experience.
  • In-depth knowledge, expertise, and hands-on experience with different chromatography types, mass spectrometry, thermal, and dissolution technologies for raw materials, APIs, impurities, and Drug products.
  • A proven track record of analytical expertise in method development and validation for early to late-stage development.
  • Extensive knowledge and hands-on experience with analytical instrumentation.
  • Evaluate analytical method validation status and robustness of methods from development through transition to commercial status.
  • Provide analytical evaluation and impact/risk assessment for proposed changes to API, raw materials, manufacturing processes, specifications, and methods.
  • Implement risk mitigation plans proactively for analytical test methods associated with in-process control, release, and stability testing.
  • An in-depth knowledge of HPLC and GC, including both theory and practice.
  • Experience with the USP4 Flow-through dissolution testing method is a plus.
  • Ability to travel as needed to support customers with method transfers on site.


» Job description


Employer:
SOTAX AG
Location:
Westborough, MA [Vereinigte Staaten]
Temporary:
No
Part-time:
No