- 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.
- This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following: sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment's.
- Working in an analytical laboratory handling chemical reagents that may be hazardous (corrosive, toxic, flammable etc.).
- Office work, teleconferencing, computer work, leading meetings requiring working in open office environment, working alone and working with/around others
- 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.
- Works independently and collaborates with other groups. Deliver results in line with project and team objectives.
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Summit, NJ are encouraged to apply.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays