Research Associate, Drug Product Development

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. Learn more at Astellas.com.

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

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

• →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.
• →Execute protocols & batch records with some guidance and summarize results independently.
• →Growing technical knowledge and continued understanding of operations to start troubleshooting 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

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

• 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

• 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. This individual will also work closely with other functions such as Process Readiness, Analytical Development, MSAT and Manufacturing.

• 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.

$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.)