Job Description
The Analytical Development group is seeking a laboratory based role with CMC experience in biologics at the Senior Scientist level to join advancing early stage protein therapeutics programs. The candidate will develop a wide variety of chromatography, and other biological activity and process impurity assays for biologics drug candidates at all stages of development with a particular focus on critical program needs including CMC development for INDs and BLAs. An ideal candidate will have experience in drug development, including experience as a participant on CMC/Technical teams. A good scientific understanding of protein biophysical chemistry and activity assays is essential.
KEY RESPONSIBILITIES
- Execution of relevant experiments to support development, qualification and optimisation of analytical assays for biologics in development
- Develop a relevant tool box of qualitative and quantitative assays for process development as well as product characterization, including release assays to follow critical quality attributes
- Understand CMC needs, deliverables, timelines, responsible for delivery of results and proactively plan work and resources for timely execution
- Author and/or review key regulatory documents including IND and BLA sections collaboratively and as needed, laboratory data, technical memos and reports
- Generation of analytical methods, qualification reports, results & share with collaborators; present data proactively and regularly in group meetings; communicate plans and results to collaborators and manager iteratively
- Train and mentor colleagues and associates when needed
- Engage the broader scientific community through poster and oral presentations at industry conferences and publications
- BSc, MSc in biological sciences, preferably biochemistry, biophysical characterization of proteins. 7 years of relevant experience in academia or in industry will be considered for a Scientist position. 10 years of relevant experience in academia or in industry will be considered for a Senior Scientist position.
- Strong knowledge of protein chemistry, structure, and function. Familiar with common protein post-translational modifications and characterization methods
- Experienced in method development of biochemical, LC-MS, and/or bioassay methods for characterization of proteins, qualification, and transfer
- Experience with late-stage therapeutic protein characterization for BLA and regulatory document drafting preferred
- Previous experiences with studies on antibody structure-function relationship with CQA assessment preferred
- Experience in other advanced bioanalytical techniques, such as cIEF, CE-SDS, SEC-MALS, AUC, CD, particle analysis preferred and excellent assay troubleshooting skills. A working knowledge of Empower, Fusion, LIMS, Nugenesis, VMS and QDMS is highly desirable.
- Excellent communication (oral and written) and interpersonal skills; ability to work well with a wide range of functional groups including R&D, QC, QA, Regulatory Affairs, and Commercial Operations
- Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment
- Understanding of ICH, USP, Ph Eur, FDA and relevant guidelines for CMC development; interest in developing CQAs
- Good time and project management skills, and ability to work on several projects simultaneously. Good organizational and communication skills