Research Associate, Drug Product Development

About the Company

Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology, and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

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. This individual will execute protocols with some guidance and summarize results independently, collaborating closely within the team and across functional groups to advance pipeline programs.

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, cell and molecular biology to generate data in an accurate and reproducible manner.
• Executes protocols and batch records with some guidance and summarizes results independently.
• Develops technical knowledge and troubleshoots technical problems with guidance from supervisor.
• Conducts experiments after discussion of the design and strategy with the supervisor.
• Performs literature searches and analysis as needed for drug product development.
• Contributes to the writing of 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

• BS with 3+ years or MS with 0-2 years’ experience in the biotechnology field.
• Proficient in aseptic technique, mammalian cell culture, and cell characterization techniques.
• Ability to support writing of SOPs, maintain accurate records, and 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.
• Able 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.

Preferred Qualifications

• Previous experience with pluripotent stem cells and cell-based assays.
• Proficiency with data analysis software (e.g., 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.

Location and Working Environment

This position is based in Westborough, MA and will require on-site work. The Research Associate reports to a Scientist within Drug Product Readiness and will collaborate with other members of the drug product development team, as well as other functions such as Process Readiness, Analytical Development, MSAT, and Manufacturing.

What Awaits You at Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Organizational Values and Behaviors

• Values: Innovation, Integrity, and Impact sit at the heart of what we do.
• Behaviors: We come together as ‘One Astellas,’ working with courage and a sense of urgency. We are outcome-focused and consistently take accountability for our personal contributions.

Pay

Salary Range: $69,790–$99,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations.)

Benefits

• Medical, Dental, and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 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