Scientist, Analytical R&D

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

Job Responsibilities:

Under supervision, works on analytical method development, optimization, troubleshooting, qualification, and validation in areas related to some or all the following: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, GC, and other small molecules and/or large molecules characterization methods.
Apply routine and specialized analytical techniques to characterize and quantify small molecules such as linker payload and ADCs.
Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
Prepare high-quality technical presentations and present internally and externally and participate in scientific discussions.
Stays abreast of current literature in scientific areas
Authoring analytical test methods, protocols, reports and other documents.
Maintains lab equipment, orders supply for lab and provides general lab support.
Perform other tasks and assignments as needed and specified by management.

Qualifications

Required Skills and Knowledge:

Must have practical experience with some or all the analytical instruments such as LC (SEC, RP, IEX, HIC etc.), capillary electrophoresis and GC for method development, optimization and validation of analytical methods.
Experience with the application of separation, compendial, and spectroscopic techniques for the characterization of linker payloads and ADCs including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (CE, cIEF) is plus.
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 same time.
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.

Education and Experience Requirement

Ph.D. in Analytical Chemistry or Organic chemistry or Biochemistry, or related areas with 0-3 years industry experience
Masters degree in chemistry or relevant filed with 3 to 5 years.
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.

Working Conditions:

Office/ Laboratory environment

Compensation

$70,000- $110,000 per annum

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.