Research Associate, Drug Product Development

About the Role

The Research Associate II will support drug product development activities including formulation screening, process development and optimization, in-use evaluation, and analyzing data. The Research Associate will execute protocols with some guidance and summarize results independently. This individual will collaborate closely within the team and across functional groups to advance pipeline programs.

Key Responsibilities

• Contributes to drug product process development and technical transfer activities through cell culture, formulation screening, and product characterization studies.
• Utilizes established techniques in cell culture and cell and molecular biology to generate data accurately and reproducibly.
• Executes protocols and batch records with some guidance and summarizes results independently.
• Troubleshoots technical problems with guidance from a supervisor.
• Conducts experiments after discussion of design and strategy with a supervisor.
• Performs literature searches and analysis for drug product development.
• Contributes to writing technical reports detailing procedures, outcomes, and observations.
• Maintains accurate record keeping in laboratory notebooks and appropriate databases in a timely manner.
• Maintains inventory of reagents and disposables and orders supplies as needed.

Requirements & Tech Stack

• Aseptic technique
• Mammalian cell culture
• Cell characterization techniques
• Ability to support writing of SOPs
• Ability to maintain accurate records
• Ability to analyze data
• Knowledge of cell biology and/or product development
• Capable of meticulous GDP/record keeping
• Willingness and ability to learn new skills and knowledge
• Ability to work independently, as well as part of a team
• Self-reliant, self-motivated, and highly organized
• Ability to collaborate with internal and external partners across multiple scientific disciplines
• Excellent written and oral communication skills
• Ability to occasionally work a flexible schedule based on experiment needs.

Qualifications

• BS with 3+ years or MS with 0-2 years’ experience in the biotechnology field.

Preferred Qualifications

• Previous experience with pluripotent stem cells and cell-based assays.
• Proficiency with Data analysis software – Graphpad Prism, JMP.
• Previous GMP experience.
• Knowledge of CMC or drug product development and tech transfer.
• Knowledge of GMP, ICH, USP/JP/EU/global compendial, regulations, and guidance.