We are hiring an Associate Engineer II to join the Drug Product Process development team. The primary responsibility will be to provide technical and engineering support across drug product process development activities, spanning late-stage clinical supply, process characterization, tech transfer, and commercial readiness.
This is a 12-month contract based in San Carlos, CA.
Responsibilities
- 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 drug product 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.
Qualifications
- 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.
Salary
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance – PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
