Research Associate II, Drug Product Development

Astellas Pharma • Westborough, MA

6d • $69,790 - $99,700 • Onsite

About The Position

The Research Associate II supports drug product development activities, including formulation screening, process development and optimization, in-use evaluation, and data analysis. The role executes protocols with some guidance and independently summarizes results. The associate collaborates within the team and across functional groups to advance pipeline programs. This position is based onsite in Westborough, Massachusetts, and reports to a Scientist within Drug Product Readiness.

Requirements

• Bachelor of Science with at least 3 years of biotechnology-field experience, or Master of Science with 0–2 years of experience.
• Proficiency in aseptic technique, mammalian cell culture, and cell characterization techniques.
• Ability to support SOP writing, maintain accurate records, and analyze data.
• Knowledge of cell biology and/or product development.
• Ability to maintain meticulous GDP records.
• Willingness and ability to learn new skills and knowledge.
• Ability to work independently and as part of a team.
• Self-reliant, self-motivated, and highly organized.
• Ability to collaborate with internal and external partners across scientific disciplines.
• Excellent written and oral communication skills.
• Ability to occasionally work a flexible schedule based on experiment needs.

Nice To Haves

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

Responsibilities

• Contribute to drug product process development and technical transfer activities through cell culture, formulation screening, and product characterization studies.
• Use established cell culture, cell biology, and molecular biology techniques to generate accurate and reproducible data.
• Execute protocols and batch records with some guidance and independently summarize results.
• Develop technical knowledge and understanding of operations, and begin troubleshooting technical problems with supervisor guidance.
• Conduct experiments after discussing design and strategy with the supervisor.
• Perform literature searches and analysis as needed for drug product development.
• Contribute to technical reports detailing procedures, outcomes, and observations.
• Maintain accurate, timely records in laboratory notebooks and appropriate databases.
• Maintain inventory of reagents and disposables and order supplies as needed.
• Collaborate with drug product development colleagues and other functions, including Process Readiness, Analytical Development, MSAT, and Manufacturing.

Benefits

• Medical, dental, and vision insurance.
• Paid time off options, including vacation and sick time, plus national holidays and a year-end shutdown.
• 401(k) match and annual company contribution.
• Company-paid life insurance.
• Annual corporate bonus and quarterly sales incentive for eligible positions.
• Long-term incentive plan for eligible positions.
• Company fleet vehicle for eligible positions.
• Referral bonus program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level