Scientist- Analytical Development

Our client is seeking a dynamic and experienced Scientist to join its Analytical Development team. In this role, you will be responsible for the development and qualification of analytical methods for peptide and recombinant drug substances as well as nanoparticle drug products. You will play a crucial role in ensuring the quality, safety, and efficacy of our pharmaceutical products while supporting the development of innovative drugs.

Key Responsibilities:

Performing analytical development activities for the testing and characterization of peptides, recombinant proteins, and nanoparticle based parenteral drug products utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis and a number of other characterization techniques.

• Development and qualification of analytical methods within cGMP compliance.
• Designing and conducting stability, impurity, and degradation studies.
• Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions.
• Providing subject matter expertise relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
• Working cross functionally with Process Development, Manufacturing, MSAT, Regulatory, and Quality Assurance departments.
• Support R&D, GMP characterization, release, and stability testing
• Author and review technical documentation, including but not limited to, protocols, standard operation procedures (SOP), work instructions, records, and reports
• Perform peer review of analytical test records
• Perform routine calibration, maintenance, and operation checks on laboratory equipment
• Execute and document all work according to policies and procedures
• Work collaboratively with and support Development Lab

Qualifications:

• BS+ Degree in Biology, Chemistry, Bioengineering, Chemical Engineering, Biochemistry, or related field.
• 1+ years of experience in analytical development
• Recombinant Protein Analytical expertise
• Parenteral Drug Product Analytical expertise
• Expertise working with HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, ELISA, gel electrophoresis, nanoparticle characterization, microbial methods.
• Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired.
• Experience working on method transfer and validation activities within cGMP compliance.
• Ability to efficiently prioritize, manage, and complete multiple projects in a fast-paced environment.
• Proficient with a broad spectrum of analytical techniques applicable to particle-based drug delivery systems (e.g. particle size, plate-based assays, SEM, FTIR, mass spectroscopy, HPLC, etc.)
• Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
• Must possess effective verbal and written communication skills.