This senior scientist role focuses on all aspects of analytical methods, including development, optimization, troubleshooting, qualification, and validation. The work involves various techniques such as LC, mass spectroscopy, icIEF, and capillary electrophoresis for small and large molecules. The incumbent collaborates cross-functionally with internal departments and external resources on analytical research and ensures adherence to regulatory requirements and company SOPs.
Responsibilities
Independently work on analytical method development, optimization, troubleshooting, qualification, and validation in areas related to LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (TOF, QTOF & SEC-MS), cIEF, capillary electrophoresis, and other small and large molecules characterization methods
Independently plan project responsibilities as a Subject Matter Expert for analytical methods, execute activities against timelines, and lead project scientific discussions in client meetings
Troubleshoot complex analytical problems involving chromatography, mass spectrometry, sample preparation, instrument performance, and column variability
Independently author and review analytical test methods, protocols, reports, and other documents
Review and interpret analytical data, chromatograms, spectra, calculations, and laboratory notebooks to ensure scientific accuracy, data integrity, and compliance
Contribute to continuous improvement of laboratory processes, analytical procedures, documentation practices, and quality systems
Prepare and present project status and progress updates to clients
Stay abreast of current literature in scientific areas
Liaise with purchasing to follow up on arrivals and help procurement with selection of materials
Perform other tasks and assignments as needed and specified by management
Requirements
Hands-on working experience and deep knowledge in analytical method development, optimization, troubleshooting, qualification, and validation of methods such as LC (SEC, RP, IEX, HIC etc.), mass spectroscopy (TOF, QTOF & SEC-MS), icIEF, Capillary Electrophoresis, and other large molecules characterization methods
Work experience with antibody-drug conjugates (ADCs) development, bioconjugates
Working experience on control strategies for large molecules for DS and DP, phase appropriate national and international regulatory filing strategies
Able to develop and execute independently and/or collaboratively all aspects of analytical methods to support bio-conjugation team, process development, product development, in-process monitoring, stability studies for APIs/drug substances/bioconjugates including authoring and reviewing analytical methods, protocols, and reports for clients and stakeholders
Ability to handle multiple projects simultaneously
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Be a Subject Matter Expert for the team and support assay troubleshooting, investigations, and improving analytical methods and interpret complex data and perform statistical analysis using appropriate software
Exhibit strong departmental leadership for best practices of technique, instrumentation, regulatory strategy, project management, processes, information organization, and communication
Able to communicate scientific data effectively through presentations, protocols, test methods, and reports internally and externally
Maintain a culture of safety and ensure safe work practices within the lab
Adhere to company EHS and quality standards, regulations, and company policies, procedures, and mission
Communicate effectively with supervisors, colleagues, clients, and vendors
Proficiency with Microsoft Office
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfill business need
Ph.D. in Analytical Chemistry or Organic Chemistry or Biochemistry, or related areas with 2 – 4 years’ experience or master’s degree in chemistry or relevant field with 5 to 7 years
Proven track record of industry experience
Proven track record in analytical method development, project leadership and problem solving in the pharmaceutical or biotech industry
At least 1 year of GMP experience
Nice to have:
LC/MS method development for characterization of mAb’s, ADC and Oligo-antibody conjugates