Sr Associate

Process Development Senior Associate

Company is currently seeking an external worker to join our 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 closely with the automation team responsible for the technical aspects of enabling automation and advancing Company's drug product commercialization.

Responsibilities:

• Plan and execute studies to characterize and enable implementation of new technologies that advance state-of-the art automation, high throughput screening and analytical capabilities.
• Plan and execute studies to characterize drug product formulations and processes
• Effectively communicate and collaborate with the colleagues inside the automation team to coordinate, organize and execute studies
• Evaluate product attributes through analytical testing, e.g. measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, subvisible and visible particle characterization.
• Apply fundamental scientific and engineering principles (chemistry, kinetics, statistics, etc.) to solve challenges
• Participate in data management initiatives, such as integration of data from lab instruments with Electronic Lab Notebooks (ELN) to streamline and automate data collection
• Author/review technical documents, such as technical presentations, protocols, and reports.
• Actively involve and support safety and compliance initiatives in the lab, including resolution of safety observations

Preferred Qualifications:

• Prior knowledge or industry experience (1+ years) of pharmaceutical/biotechnology process development and protein handling and processing esp. formulation development and Drug Product unit operations, e.g. UF/DF, filling, lyophilization
• Hands-on experience in executing protein characterization techniques, i.e. SEC-UHPLC or CEX-UHPLC, concentration measurement via UV-Vis, pH, viscosity and other analytical testing.
• Basic understanding of, or prior experience with, automated and high-throughput laboratory systems, including liquid-handling platforms and analytical instruments.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions/SOPs, and comply with company policies
• 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

Basic Qualifications:

• Bachelor's degree (with 2+ yrs of industry experience) or master's degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or related subject area with biotechnology or pharmaceutical background.
• Familiarity with protein handling and processing through biotech/pharmaceutical industry experience

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…