USA - Scientist

Job Summary

Advance your biopharmaceutical career with a top-tier global pharma leader! We are seeking a Contract Scientist to provide dedicated technical and operational support across mid-stage and late-stage parenteral drug product development programs.

Responsibilities

• Design and execute in-use studies for parenteral products, including dose preparation, dilution, compatibility, hold-time, and simulated clinical administration.
• Perform physicochemical and analytical characterization (MFI subvisible particles, SEC, pH, osmolality, and protein concentration) to trend stability data.
• Author technical protocols, plans, and reports to support clinical administration instructions and regulatory filings.
• Oversee sample management, testing logistics, and stability pull schedules with analytical and quality laboratories.
• Maintain inspection-ready electronic document management systems (EDMS) adhering strictly to GMP, GDP, and data integrity standards.

Qualifications

• B.S. with 6+ years, M.S. with 4+ years, or Ph.D. with 0-2 years of biotech experience in Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields.
• Proven background in parenteral/sterile drug product formulation, development, or manufacturing support.
• Hands-on experience with in-use, compatibility, and stability studies for injectable/infusion products.
• Solid laboratory expertise in analytical characterization (SEC, MFI, pH, osmolality, appearance).
• Demonstrated experience authoring technical reports and navigating EDMS tools (e.g., Veeva, Documentum).
• Practical understanding of GMP, GDP, and regulatory expectations.

Skills

• Chromatography
• Good Manufacturing Practices (GMP)
• Good Documentation Practices (GDP)
• International Council for Harmonization (ICH)
• Chemistry Manufacturing and Controls (CMC)

Pay

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term disability
• 401K plan