Biotechnology company is hiring an Associate Engineer to join the Drug Product Process Development team. You will support the Drug Product process development of pre-clinical programs through to the phase 3 and commercial readiness of the lead program. The ideal candidate has a background in aseptic manufacturing or process development, with hands-on experience in mixing small molecules and biologics, and a strong understanding of Fill-Finish operations-ideally from clinical manufacturing, pilot plant, or even food science environments.
This is a 6-month contract, potential extension.
Responsibilities
- Contribute to the development of a robust process for early-stage Drug Product manufacturing by designing, planning, and executing relevant experiments and performing data analysis to select key process parameters and appropriate operating conditions.
- Enable the team in general process design, including contact material selection, hardware design/construction, filter selection/sizing, mixing and filling activities at different scales.
- Provide engineering support, in conjunction with the CMO to generate the appropriate solutions for successful technology transfer of Drug Product manufacturing to CMO.
- Collaborate with the Drug Product Formulation and Analytics teams to troubleshoot and optimize the Drug Product as required for phase 1 to phase 3 and commercial needs.
- Collaborate in drafting and reviewing manufacturing batch records, technology transfer report, among other important documents.
Qualifications
- Bachelor's degree in chemical engineering, pharmaceutical sciences/engineering, physical sciences and 2 years of experience or Masters degree and 1 year of experience.
- 2+ years of experience in drug product manufacturing or aseptic processing and operations.
- Experience in early and/or late-stage clinical manufacturing within fill finish sites under GMP regulations is preferred.
- Apply knowledge of pharmaceutical science and engineering to overcome challenges around drug product manufacturing and scale up.
- Experience in the development of scale up/down models for DS or DP processes.
- Ability to perform and document drug product process development and characterization experiments while adhering to scientifically-sound practices, including the design, execution, review, and interpretation of experiments.
- Prior experience with adjuvant biologics is a plus.
- Prior experience with data analysis software such as Excel and JMP is preferred.
Pay
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.