Sr. Scientist II - Biotech , Mass Spec

Responsibilities

• Demonstrates strong expertise in biochemistry, mass spectrometry, chemistry, and protein chemistry.
• Develops and validates methods to determine purity, potency, identity, residuals, and characterization of pharmaceutical and biopharmaceutical products.
• Supports analytical studies for peptides, proteins, nucleic acids, carbohydrates, cell & gene therapy products, as well as small molecule drugs in parenteral, solid dosage forms, transdermal patches, intermediates, and APIs.
• Maintains an expert knowledge and mastery of equipment, instrumentation, procedures, and scientific methodologies necessary to perform complex research or projects.
• Performs routine analytical procedures necessary for support of formulation development, manufacturing, and QC stability activities.
• Documents results in electronic laboratory notebook.
• Evaluates and interprets analytical data.
• Writes standard operating procedures (SOPs), test procedures, specifications, protocols, project reports (e.g., development/validation), and client communications.
• Positively interacts with team members, management, and clients to discuss data and project progress.
• Leads deviations, investigations, and root cause analysis.
• Participates in regulatory agency and/or client audits.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Safely handles potent compounds.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Participates in scientific conferences and contributes to scientific journals.
• Ledds and mentors associate scientists.

Qualifications

• Bachelor’s degree in Biochemistry, Chemistry, or related field with minimum 10 years of experience.
• Master’s degree in Biochemistry, Chemistry, or related field with a minimum of 6 years’ experience.
• Doctoral degree in a related field with a minimum of 4 years’ experience.
• 5+ years of experience in Pharmaceutical/Biopharmaceutical analytical drug product development under cGMP.
• Demonstrated experience in development, validation and troubleshooting chromatographic, electrophoretic, mass spectrometry and other spectroscopic methods for one or more of the following products: peptides, monoclonal antibodies/recombinant proteins, nucleic acids, cell therapy, and gene therapy.
• CDMO experience is preferred.