Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Malvern, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a
Scientist, Proteins, Analytical Development.
Purpose: The Therapeutics, Development & Supply (TDS), Proteins Analytical Development (AD) is recruiting for a Scientist who will conduct peptide mapping method development and qualification activities on monoclonal antibodies, bi- and tri-specific antibodies and antibody drug conjugates.
You will work and grow in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.
You will be responsible for:- Operate state-of-the-art LC and MS instrumentation
- Learn and apply different software packages for LCMS/protein analysis
- Perform LCMS-based quantitation of post-translational modifications
- Design and implement peptide mapping / MS experiments on antibodies and recombinant proteins to assess sequence coverage and sites of modification
- Participate in IND, IMPD, BLA, and other regulatory filings
- Develop test methods, provide documentation and write scientific reports.
- Conduct testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations
- Lead or facilitate technical discussions and participate in cross-functional teams at project-related meetings
Qualifications / Requirements:
Education:- A master's degree with 5+ years, or a bachelor's degree with 9+ years of relevant biochemical experience
Experience and Skills:Required:- Proven scientific expertise with extensive hands-on experience with LC-MS
- Knowledge of method robustness, method design and familiarity with assay validation parameters
- Excellent organization, communication, presentation skills and scientific/technical writing skills
- Proficiency at running and trouble-shooting assays
- Able to manage multiple tasks, handle tight timelines and deliver quality data
Preferred:- Experience peptide mapping method development and qualification activities on monoclonal antibodies, bi- and tri-specific antibodies and antibody drug conjugates
- Excellent interpersonal skills
- Experience with commercialization of therapeutic proteins
- An understanding and experience in the application of various GXP concepts
- Experience preparing reports, protocols and SOPs
#LI-Onsite
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression
