Responsibilities:
- Utilize analytical techniques to conduct R&D studies related to small-molecule drug products, peptides, active pharmaceutical ingredients, intermediates, starting materials, impurities, and impurity profiling.
- Apply analytical separation and detection modes for complex impurity profiling to support emerging cGMP manufacturing processes.
- Independently design and conduct critical experiments to further project goals.
- Interpret results, note deviations, and suggest/design/pursue relevant experiments.
- Implement and may innovate new experimental protocols/techniques.
- Perform routine and complex tasks independently to generate reliable results (lab and/or pilot plant based activities).
- Maintain high proficiency in assigned projects and overall program goals.
- Understand and apply scientific literature and theoretical frameworks to solve problems timely.
- Adhere to corporate standards on code of conduct, safety, material handling, controlled drug/radioactive compounds, GxP compliance, and animal care (where applicable).
Qualifications:
- Bachelorโs degree (or equivalent) with 5+ years experience, or Masterโs degree (or equivalent) with 2+ years experience.
- Theoretical/practical knowledge of ICP/MS, ICP, and MS.
- Understanding of cGMP and current regulatory requirements.
- Strong analytical chemistry background; ability to develop and troubleshoot analytical methods.
- Ability to independently design, execute, and interpret critical experiments.
- Ability to learn and master new experimental techniques.
- Hands-on HPLC analysis and method development; knowledge of spectroscopic techniques.
- Experience with computerized data handling, data analysis, and statistical approaches.
- Ability to multitask and meet timelines; self-motivated, detail-oriented.
- Strong written/oral communication; ability to collaborate with interdisciplinary scientists/engineers.
Preferred:
- Degree in Analytical/Physical Chemistry or Biochemistry.
- Practical knowledge of organic structure/functional groups and modern spectroscopic techniques for small-molecule analysis.
- Lab automation experience (plus).
- Experience with contract labs/external suppliers (plus).
- Experience performing lab investigations (plus).