Job Description:
Job Summary
The Associate Scientist, Analytical Development will play a key role in developing and executing mass spectrometry methods to support research and clinical programs. This is a hands-on laboratory position involving experimental design, data analysis, and interpretation to guide decision-making across cross-functional teams. The individual will contribute to analytical method development, qualification, and troubleshooting, while maintaining a strong focus on data quality, innovation, and compliance.
Key Responsibilities
-
Design and perform experiments to develop, optimize, and qualify analytical methods for release, stability, and extended characterization testing.
-
Analyze experimental data, interpret results, and propose next steps to improve methods or resolve analytical challenges.
-
Implement novel analytical and mass spectrometry techniques for characterization of biologics and complex molecules.
-
Document experiments in electronic laboratory notebooks and prepare detailed technical reports summarizing findings.
-
Present data and updates regularly in team and project meetings.
-
Ensure all work adheres to regulatory standards and internal policies, including FDA, EMA, ICH, and GMP requirements.
-
Collaborate with cross-functional teams to support research, development, and technical operations initiatives.
-
Contribute to a culture of innovation, teamwork, and scientific excellence.
Qualifications
-
Masters degree in Chemistry, Biology, or Pharmaceutical Sciences, or a Bachelors degree with at least 4 years of relevant experience in mass spectrometry analysis of biologics.
-
Hands-on experience with LC-MS/MS, HPLC, CE, and related analytical techniques.
-
Strong knowledge of antibody and/or oligonucleotide analytical characterization.
-
Demonstrated ability to analyze complex data and solve technical problems independently.
-
Excellent communication, organizational, and interpersonal skills.
-
Ability to work collaboratively in a fast-paced, multidisciplinary environment while managing multiple priorities effectively.