Description

You will focus on identifying and developing drug product aspects to advance process design for parenteral drug products.

Responsibilities

• Design, execute, and document primary data packages related to drug product design and process development.
• Develop technical solutions for process characterization and aseptic manufacturing challenges.
• Support clinical and commercial process introductions or transfers into the manufacturing network.
• Author and review technical protocols, reports, product impact assessments, and regulatory sections for IND and marketing applications.
• Provide troubleshooting and root cause analysis for fill/finish manufacturing operations, including non-conformance investigations.

Required Skills

• 3+ years of experience within the pharmaceutical or biotechnology industry.
• Hands-on experience with aseptic processing and aseptic fill/finish unit operations.
• Strong understanding of Good Manufacturing Practice (GMP) and compliance for sterile injectable products.
• Proficiency in process development and characterization.
• Experience using engineering principles to leverage bench and pilot scale models.
• Technical problem-solving skills involving root cause analysis and risk assessment tools.
• Ability to use electronic record keeping, laboratory notebooks, and statistical analysis software.
• Background in Bioengineering, Biochemistry, Biotechnology, or related sciences.

Preferred Skills

• Experience with Design of Experiments (DOE) and Quality by Design (QbD) principles.
• Knowledge of process-related stresses impacting biologic quality and stability.

Key Skills

Education

Any Graduate