Job Title: Process Development Senior Associate
Location: Thousand Oaks, CA (Fully Onsite with occasional WFH based on workload)
Job Type: Contract (1 year, potential for extension)
This group focuses on late-stage drug product formulation and fill/finish process development for large molecule modalities, such as monoclonal antibodies, bispecific T-cell engagers (BITEs), and fusion proteins.
Key Responsibilities:
- Plan, design, execute, and document studies related to drug product formulation and process development.
- Support formulation assessments using high-throughput technologies and workflows.
- Perform studies involving automation technologies, including liquid handling robots and high-throughput protein characterization assays.
- Conduct analytical testing (e.g., SEC-UHPLC, CEX-UHPLC, viscosity, particle analysis) and data analysis.
- Innovate solutions to improve throughput, data quality, and workflows.
- Collaborate with the automation team and contribute to team meetings with study designs and results.
- Author and review technical documents such as protocols, reports, and presentations, ensuring data accuracy and integrity.
Basic Qualifications:
- BS with 2–5 years of relevant experience OR MS with 0–3 years of experience in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related fields.
- Industry experience in biotechnology, pharmaceutical, or vaccine development preferred.
Preferred Qualifications:
- Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or a related field.
- 2+ years of experience in pharmaceutical/biotechnology process development and protein handling.
- Hands-on expertise with protein characterization techniques (e.g., SEC-UHPLC, CEX-UHPLC, UV-Vis concentration measurement).
- Experience with automation platforms such as Tecan, Hamilton, or Unchained Labs.
- Strong critical thinking, problem-solving, and independent research skills.
- Exceptional attention to detail, organization, and communication skills.
- Ability to thrive in a fast-paced, dynamic, and matrixed team environment.