Process Development Senior Associate

Thousand Oaks, CA, USA

Job Type

Full Time | $28 Hourly

Workspace

Fully Onsite - Occasional WFH opportunities based on teams workload. Regular working hours

About the Role

• Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development by:
- Supporting and executing formulation assessments by utilizing high-throughput technologies and workflows, working closely with program teams on fast-paced projects.
- Supporting studies on advancing automation technologies regarding liquid handling robots, plate-based buffer exchange systems, and high throughput protein characterization assays.

• Evaluate product and process performance through analytical testing (e.g., U/HPLC, CEX, particle analysis, physical properties, etc.) and perform subsequent data analysis and method compliance assessments as appropriate.
• Identify and implement innovative solutions by applying basic science/engineering skills to increase throughput, improve quality, and streamline data capture and analysis.
• Effectively communicate and closely collaborate with the colleagues in the automation team to coordinate, organize and execute studies
• Participate in team meetings by sharing study designs, results, and technical challenges.
• Author and review technical documents, such as technical presentations, protocols, and reports, while ensuring a high standard of data accuracy and integrity

Requirements

Preferred Qualifications:
• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related subject area.
• Prior knowledge or industry experience (2+ years) of pharmaceutical/biotechnology process development, protein handling, and processing with a focus in formulation development
• Hands-on experience in executing protein characterization techniques, i.e. SEC-UHPLC, CEX-UHPLC, concentration measurement via UV-Vis, pH, viscosity and other analytical testing.
• Hands-on experience in designing and executing automation and high throughput screening studies on liquid handling platforms (e.g. Tecan, Hamilton, Andrew Alliance, Unchained Labs, etc.)
• Critical thinking, problem solving and independent research skills• Good organizational skills with strong attention to detail
• Ability to elevate relevant issues to project lead and line-management
• Self motivation, adaptability and a positive attitude with enthusiasm to learn new techniques
• Ability to work independently and as part of a team with internal and external partners
• Ability to participate and work effectively in a fast-paced, dynamic and highly matrixed team environment• Good organizational skills with strong attention to detail.
• Excellent communication (oral and written)