ProClinical is recruiting for an exciting new position in Bioassay Development, as a Principal Scientest based in Cranbury, NJ. The ideal candidate will be responsible for developing, qualifying, validating and transferring of robust biological test methods. Additionally, the candidate will be responsible for planning, executing, analyzing and reporting all outcomes and methodology of experiments related to the development and characterization of biosimilars in all stages of development. The role will report to the Executive Director of Process Development.
- Lead a team of 2-4 other scientists.
- Serve as bioassay expert for all related activities.
- Develop, implement and execute the required biological assays to enable the robust characterization of biosimilar monoclonal antibodies.
- Support process development enabling activities including in-process testing, drug substance, drug product, extended characterization and comparability.
- Support the established regulatory plan with respect to compliance-related bodies.
- Support bioassay group’s effort to maintain focus on established technologies.
- Lead the bioassay discipline.
- Develop, qualify and validate required methods to global regulatory standards.
- Collaborates and communicates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
- Evaluate opportunities for improving robustness of existing biological methods.
- Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions, premarket approval applications, and post-marketing submissions.
- Build department of scientific excellence to enable prosecution of mAb biosimilar pipeline.
- Represent the Company before EU and FDA regulatory authorities.
Skills And Qualifications
- MS or PhD in cell biology, life sciences, or equivalent.
- 10+ years progressive industry experience.
- Experience in authoring a successful BLA/MAA.
- Experience with mammalian cell techniques and be able to maintain multiple cell cultures and cell line types
- Experience with multiple assay platforms such as cell based assays, ELISA, SPR etc.
- Experience with Forte Bio Octet, Biacore and FACS
- Experience with CRO/CMO evaluation and analytical method transfer especially with respect to biological assays
- Support the continuous improvement of quality systems required for the release and stability testing of biologics
- Strong understanding of Quality by Design and Risk Management
- Excellent English written and verbal communication skills.
- Excellent problem-solving skills.
- Hands-on, enjoys challenges.
- Highly organized, with the ability to change priorities.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank at (+1) 2674056996 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.