Associate Engineer II (Contract), Drug Product Process Development

Essential Functions

• Support the development, characterization, and qualification of robust Drug Product processes for late-stage clinical and commercial manufacturing.
• Execute bench- and pilot-scale process development studies using down-scaled models, including compounding/mixing, sterile filtration (filter selection and sizing), fill/finish, hold time, and container/closure evaluations.
• Perform in-process sample testing and analysis of DP intermediates and finished product to support process monitoring, process characterization, and release.
• Maintain accurate and timely data entry and documentation in Benchling (ELN) in accordance with Good Documentation Practices (GDP), ensuring accuracy, completeness, and compliance with established standards and regulatory requirements.
• Analyze experimental and manufacturing data using statistical tools (e.g., JMP), identify trends, and summarize findings in technical reports and presentations.
• Perform routine lab upkeep and housekeeping to ensure laboratory cleanliness standards are met and conduct regular inventory monitoring and reconciliation.
• Work within a team environment and provide support as necessary to further the team’s initiatives.

Requirements

• BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Experience in, or exposure to, early- and/or late-stage clinical fill/finish manufacturing under GMP regulations preferred.
• Working knowledge of Drug Product unit operations, such as compounding/mixing, sterile filtration, aseptic fill, and container/closure systems (vials, PFS, cartridges).
• Experience supporting technology transfer, scale-up/scale-down, process characterization, or CDMO-based manufacturing activities is preferred.
• Familiarity with statistical analysis tools (e.g., JMP, Minitab) is preferred.
• Experience using electronic lab notebook (ELN) systems, preferably Benchling, is a plus.
• Strong interpersonal and communication skills, both verbal and written, with the ability to work effectively with internal cross-functional teams.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment, managing multiple priorities simultaneously.
• Ability to execute, document, and interpret drug product process development and characterization experiments, adhering to scientifically sound practices.
• Strong technical writing, data analysis, and communication skills.

Reports to

Engineer I, Drug Product Process Development

Location

San Carlos, CA

Expected Contract Length

12 months

Pay

Hourly Range: 51/hr. – 56/hr.