Sr Associate

Process Development Senior Associate High-Throughput Drug Product Technologies

This role is a Senior Associate position within a high-throughput drug product technologies team focused on late-stage drug product formulation and fill/finish process development for large molecule modalities, including monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins. The Process Development Senior Associate will closely collaborate with an automation-focused group to enable advanced laboratory automation, high-throughput screening, and analytical capabilities that support drug product commercialization.

Responsibilities:

• Plan and execute experimental studies to characterize and enable implementation of new technologies that advance state-of-the-art automation, high-throughput screening, and analytical capabilities for drug product development.
• Design and perform studies to characterize drug product formulations and fill/finish processes for large molecule modalities, ensuring robust and scalable process performance.
• Communicate and collaborate effectively with colleagues in the automation team to coordinate, organize, and execute studies, aligning timelines, resources, and technical objectives.
• Evaluate critical product attributes through analytical testing, including measurement of pH, conductivity, osmolality, protein concentration, size-exclusion chromatography (SEC), cation-exchange chromatography (CEX), and subvisible and visible particle characterization.
• Apply fundamental scientific and engineering principles, such as chemistry, kinetics, and statistics, to troubleshoot issues, interpret data, and solve complex technical challenges in formulation and process development.
• Participate in data management initiatives, including integration of data from laboratory instruments with Electronic Lab Notebooks (ELN), to streamline, standardize, and automate data collection and reporting.
• Author and review technical documents, including study protocols, technical reports, and presentations, ensuring clear documentation of experimental design, results, and conclusions.
• Support and actively engage in laboratory safety and compliance initiatives, including identification and resolution of safety observations and adherence to standard operating procedures.
• Maintain accurate, detailed experimental records, follow established SOPs, and comply with all relevant policies and guidelines.
• Collaborate with internal and external partners, contributing to project discussions, sharing results, and elevating relevant technical or operational issues to project leadership when needed.
• Work effectively in a fast-paced, dynamic, and highly matrixed team environment, balancing multiple tasks and priorities while meeting project timelines.

Essential

Skills:

• Bachelors degree with 2 years of industry experience, or a masters degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or a related discipline with a biotechnology or pharmaceutical background.
• Industry experience in pharmaceutical or biotechnology process development with familiarity in protein handling and processing, particularly formulation development and drug product unit operations such as ultrafiltration/diafiltration (UF/DF), filling, and lyophilization (preferred: 1 year or more).
• Hands-on experience executing protein characterization techniques, including SEC-UHPLC or CEX-UHPLC, concentration measurement via UV-Vis, pH measurement, viscosity assessment, and other analytical testing methods.
• Familiarity with protein handling and processing gained through biotech or pharmaceutical industry experience.
• Basic understanding of, or prior experience with, automated and high-throughput laboratory systems, including liquid-handling platforms and analytical instruments.
• Ability to learn new laboratory techniques quickly, perform multiple tasks simultaneously, and keep accurate and organized experimental records.
• Capability to follow instructions and standard operating procedures (SOPs) while complying with applicable policies and guidelines.
• Strong critical thinking and problem-solving skills, with the ability to conduct independent research and interpret complex data sets.
• Good organizational skills and strong attention to detail in planning, executing, and documenting experiments.
• Ability to identify and elevate relevant technical or operational issues to project leads and line management in a timely manner.
• Demonstrated ability to work independently as well as collaboratively within…