Senior Scientist, Large Molecule Bioanalytics
- Responsible for the development of robust and reliable bioanalytical assays suitable for the quantitation of biotherapeutics in various biological matrices using ligand-binding, cell-based and/or PCR methodologies.
- Responsible for the development robust and reliable ligand binding assay and /or cell-based assays suitable for characterizing the immunogenicity of biotherapeutics in various biological matrices using a range of potential platforms and assay techniques.
- Validation and implementation of assays to be governed per departmental SOPs and GLP / GCP regulations
- Lead and collaborate with other colleagues in a matrixed team environment.
- Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.
- Design, develop and implement ligand-binding and cell-based assays using different platforms (e.g. ELISA, ECL, Gyros) in biological matrix (plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated (GLP, GCP) environment against challenging time lines.
- As appropriate, participate in the establishment of PCR methods to support gene therapy programs.
- High degree of independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs.
- Collaborate with inter-departmental partners to ensure that bioanalytical methods meet scientific requirements for support of clinical and nonclinical studies.
- Timely delivery of concentration and immunogenicity data to inter-departmental partners in compliance with local or global regulatory requirement
- Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
- Supervise the activities of junior staff members, guiding them in the design and interpretation of experiments.
- Authors reports and protocols, and presents findings to peers and management as required.
Qualifications BASIC QUALIFICATIONS
- BS in a relevant discipline, with 9+ years of bioanalytical laboratory experience, or MS degree with 6+ years’ experience or PhD with 3+ years’ experience.
- Demonstrated skills in ligand-binding assay development.
- Excellent communication and presentation skills
- Experience in cell culture and bioassay techniques
- Knowledge and exposure to PCR and other molecular biological techniques
- Knowledge and experience working in a regulated environment
- Eligible for Employee Referral Bonus: Yes
- Eligible for Relocation Package: No