Analytical Development Scientist
Position Overview: Wheeler Bio is seeking a motivated analytical mind with a passion for problem solving, fast-paced environments, and expertise in protein mass spectrometry to join the analytical team. The Analytical Development Scientist will participate in the development of robust analytical techniques designed for seamless transition to a quality control environment in a manner to emphasize “right first time” and prolonged success. The position will require broad scientific knowledge of bioanalytical techniques that are used to assess and characterize proteins with a focus on monoclonal antibodies.
Key Responsibilities:
Analytical program management:
• Manages client analytical programs with a focus on quality and timeline.
• Leads analytical method development, transfer, and qualification of robust, fit-for-purpose methods to support cGMP testing.
• Designs, participates in, and reviews required analytical testing according to pre-defined plans and protocols.
• Writes and reviews analytical plans, protocols, SOPs, and summary reports.
• Leads transfer of analytical methods to Quality Control.
• Collaborates with team members and clients to troubleshoot and solve complex problems to meet project needs.
Data analysis and communication:
• Possesses advanced knowledge of protein biochemistry, analysis, and associated techniques.
• Independently uses and applies complex instrumentation, computer systems, and software for data acquisition and analysis.
• Applies knowledge and expertise to critically evaluate data, summarize results, and generate thorough reports.
• Clearly presents scientific information to senior management, external customers, and/or internal customers
• Generates SME content and technical documents (memos, development reports, white papers, presentations etc.).
Continuous improvement:
• Integrates ongoing quality and operational improvement strategies into workflows.
• Actively expands scientific expertise to encompass multiple analytical modalities.
• Stays abreast of new technologies in the field.
• Leads development of new analytical methods, processes, or technologies.
Training and personnel management:
• May oversee team of Analytical Development Associates
• Trains and provides guidance to team members and peers
• As appropriate, leads or participates in training Quality Control, Process Development, and Manufacturing teams performing analytical techniques.
Other duties as assigned.
Qualifications:
Preferred PhD degree (in biochemistry, chemistry, microbiology, or other life-science discipline) with previous industry experience. PhD degree with no prior experience or Master’s Degree (in biochemistry, chemistry, microbiology, or other life-science discipline) with at least 2 years of relevant experience will be given consideration.
Advanced knowledge of and experience in protein mass spectrometry (e.g. intact mass, peptide mapping) is strongly preferred.
Strong experience in development of multiple analytical techniques (e.g., HPLC, ELISA, enzyme activity, BLI/SPR, bioassays) demonstrated through industry or academic performance.
Ability to work independently with minimal supervision and professionally as part of a team.
Previous supervisory experience is preferred.
Ability to develop hypotheses, design experiments, critically evaluate data, and apply appropriate statistical analyses to resolve complex problems.
Excellent communication and organizational skills with the ability to lead multiple projects at once.
Demonstrated ability to clearly communicate scientific information and generate technical reports and presentations.
Knowledge of FDA, ICH, EMA, JP, and other regulatory guidance on CGMP manufacturing.
Experience with implementing automation equipment and techniques such as liquid handlers and high throughput analytical technologies along with experience with implementing software solutions is a plus.