Description:
Note:

• Thousand Oaks, CA - Fully Onsite - Occasional WFH opportunities based on teams workload. Regular working hours.
• Pivotal Drug Product Technologies Group as Process Development Senior Associate in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g., monoclonal antibodies, bispecific T-cell engagers (BiTEs), fusion proteins, etc.). The Senior Associate will work in a highly collaborative team focusing on high throughput and automation workflows to drive formulation screening and advance drug product commercialization.

Responsibilities include:

• 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

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).

Basic Qualifications:

• B.S. with 2-5 year experience, M.S. with 0-3 year experience, with degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related degree with a biotechnology, pharmaceutical or vaccine background. Biotech/pharmaceutical industry experience preferred.

Top 3 Must Have Skill Sets:

• 2+ years of relevant lab experience in industry.
• Related degrees in related fields: Chemical Engineering, Biochemistry, Biology, or other biotechnology or pharmaceutical subjects.
• Excellent communication (oral and written).
• Processing and handling proteins and other bio pharma materials.
• Preferred: 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.

Pay Rate- between $26- $29/Hr. on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"