Lab Analyst Pharma Services (m/f/d)
- 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.
- BS, MS or Ph.D. in Analytical Chemistry or related discipline with a minimum of 3 years of relevant work
- 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.
Westborough, MA [Vereinigte Staaten]