Job Number: 21-10984
Job Number: 21-10984
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a 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!
- The Scientist will be working within the Biologics Development (Client) organization.
- The role will involve the development, qualification and transfer of analytical separation methods used for product release, stability study and process characterizations supporting early phase programs.
- The successful candidate should be self-motivated, have excellent communication skills, be a team player, and have strong knowledge and experience in advanced bioanalytical separation sciences including chromatographic and electrophoretic methods. Desired skills include Design of Experiment (DoE), HPLC/UPLC, LC-MS, Capillary Electrophoresis, as well as biophysical characterization and biological techniques. Knowledge and experience with protein / peptide characterization and molecular and cell biology would be a plus.
- Develop, qualify, transfer and characterize bio-analytical techniques for monoclonal antibodies, recombinant proteins and Advanced Therapy Medicinal Products (ATMPs) to support product release, stability and process characterization studies under targeted timelines. Author method SOPs, development and qualification reports
- Provide training and oversight of assay performance to testing labs including CROs
- Work collaboratively across organization and sites for method readiness, transfer, performance and troubleshooting supporting early phase development projects
- Authors and reviews analytical method and validation sections in IND filing documents
- Utilize statistical tools for Design of Experiment (DoE) to optimize assay conditions and evaluate assay robustness, and to analyze and trend development data
- Actively lead and work on internal initiatives for improvement of business processes
- Evaluate new technologies and lead scientific and technological innovations for process improvement
- A degree in Biochemistry, Biotechnology, Analytical Chemistry, Molecular Biology, Virology, Chemical / Biological / Biochemical Engineering or a related discipline
- PhD with 0-5 years or MS with 7+ years or BS with 10+ years relevant experience in Biotech or Pharmaceutical industry
- A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of CE, iCE, and HPLC/UPLC (UV/FL/CAD/MS)
- Experience with protein fragmentation (CE-SDS, RPLC), charge variants (AEX/CEX/CIEF/iCIEF), N-glycans, peptide mapping and aggregation/HMW analysis (Size Exclusion Chromatography) techniques is highly desirable
- Experience with mass spectrometry and biophysical characterization is a plus
- Experience with PCR, ELISA, Western Blotting, Cell based bioassay is a plus
- Working knowledge of design of experiments and basic statistical knowledge is desirable
- Development experience for both early- and late-stage programs is highly desirable
- Excellent communication and interpersonal skills
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:
Paul Quibuyen | LinkedIn
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.