Senior Scientist, Analytical R&D

NJ BIO INC•Princeton, NJ

1d•$107,000 - $120,000•Onsite

About The Position

Independently work on all aspects of analytical methods, including method development, optimization, troubleshooting, qualification, and validation in areas related to some or all of the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, icIEF, capillary electrophoresis, and other small and large molecules characterization methods. The incumbent works cross-functionally with internal departments and external resources on analytical research related issues. The Senior Scientist, Analytical supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Must have 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 at the simultaneously.
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
Adheres 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 fulfil 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 relavant filed 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
Must have at least 1 year of GMP experience.

Nice To Haves

LC/MS method development for characterization of mAb’s, ADC and Oligo-antibody conjugates is plus.

Responsibilities

Independently works on analytical method development, method 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 plans project responsibilities as a SME for analytical methods, executes activities against timelines, leads project scientific discussions in client meetings.
Troubleshoot complex analytical problems involving chromatography, mass spectrometry, sample preparation, instrument performance and column variability.
Independently authors and reviews analytical test methods, protocols, and 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 client.
Stays abreast of current literature in scientific areas.
Liaises 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.