Job Number: 21-13344
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Research Scientist for our client in New Brunswick, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Independently perform biologics assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.
- Execute analytical testing of biologics including but not limited to compendial methods, wet chemistry techniques, Protein Concentration by UV/Vis spectroscopy (A280), Particulate Matter, and other relevant methods to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).
- Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate, robust and reproducible analytical methods for use in the GMP clinical laboratory.
- Independently execute analytical method qualification/validation (as applicable) and transfer to external QC laboratories. Carefully adhere to approved protocols, as applicable.
- Perform duties in full compliance of relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.
- Author clear, complete analytical methods and technical reports.
- Review technical documents, reports and protocols to assure technical merit, accuracy and completeness.
- Proactively provide clear, timely communication of potential issues to management.
- The candidate must have a B.S. or equivalent with 3-5 or more years relevant experience or a M.S. with 1 or more years relevant experience in biotechnology/pharmaceutical industry with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent. GMP laboratory experience is preferred.
- Experience with analysis of proteins in Research & Development environment is essential.
- The candidate must have good written communication skills. Must be able to independently author and review analytical methods, qualification / validation protocols and technical reports.
- Understanding of cGMP/GLP and GDPs practices and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is a must. Preferred candidate will have at least 2 year of experience in GMP environment.
- Experience using Electronic Laboratory Notebook (e.g. Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems for routing protocols/reports for review and approval is a plus.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.