USA - Scientist

Responsibilities

• Support the development and manufacturing of parenteral/sterile injectable drug products, including formulation development and process optimization.
• Perform compatibility, stability, and in-use studies for injectable and infusion products, including dose preparation, dilution, hold-time, filter compatibility, infusion-set compatibility, and simulated clinical administration assessments.
• Execute laboratory activities in a GMP environment, including compounding, sterile filtration, filling, and lyophilization.
• Conduct physicochemical and analytical testing using techniques such as micro-flow imaging (MFI), pH, osmolality, protein concentration, and size-exclusion chromatography (SEC).
• Author and review technical documents, including study protocols, reports, batch records, and GMP documentation, while maintaining accurate laboratory records.
• Utilize electronic document management systems such as Veeva, Documentum, or equivalent EDMS.
• Ensure compliance with GMP, GDP, ICH guidelines, SOPs, and applicable regulatory requirements.
• Collaborate with cross-functional teams to support formulation, manufacturing, analytical, and quality activities throughout drug product development.

Qualifications

• Bachelor's degree with 6+ years, Master's degree with 4+ years, or PhD with 0-2 years of relevant pharmaceutical industry experience.
• Strong experience in parenteral (injectable) sterile drug product development, formulation, and manufacturing.
• Experience performing compatibility, stability, and in-use studies for injectable or infusion products.
• Hands-on experience with compounding, filtration, filling, and lyophilization in a GMP environment.
• Experience with analytical methods including MFI, pH, osmolality, protein concentration, and SEC is preferred.
• Strong technical writing skills with experience preparing protocols, reports, batch records, and GMP documentation.
• Experience working with Veeva, Documentum, or similar electronic document management systems is preferred.
• Excellent communication, organization, and collaboration skills with the ability to work effectively in a cross-functional team.