Process Development Associate, Sr.

Description : Thousand Oaks, CA - Fully Onsite Regular working hours. Client is currently seeking an external worker to join their 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 0 Years w/ Relevant MS or equivalent 2 Years w/ Relevant BS or equivalent 4 Years w/ Relevant AS or equivalent 6 Years w/ HS 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. Day to Day Responsibilities: • Lab-based study support and analytical testing • Data analysis and documentation • Author, review, and data verify technical documents (e.g. presentations and reports) • Consistent communication of progress through meetings