Bio-Process Engineer

** About Astellas*
* 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

** Are you driven to make a real difference in the lives of patients?*
* 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.

** Purpose & Scope*
* The candidate will be involved in planning, direction, and execution of projects related with stem cell culture and differentiation. Activities will focus on maintaining and developing robust stem-cell based production and differentiation processes from small (6-well plate) to large (multi-layer Cell stacks or suspension) scales with the appropriate level of compliance and documentation suitable for cGMP manufacture. The candidate will work closely within the team and across functional groups.

The candidate should be a highly motivated self-starter who is comfortable working in a hands-on environment.

** Role and Responsibilities*
* + Responsible for experimental study and development plans, preparing required protocols, executing studies, conducting data analysis and preparation of final reports.

+ Conducts studies to confirm optimized processes to demonstrate process robust and reproducibility at the appropriate scale required.

+ Able to effectively troubleshoot technical issues or process deviations to ensure production proceeds as scheduled.

+ Support commercial readiness tasks including process scale-up, process and raw material qualification that meet compliance requirements.

+ Duties, responsibilities and activities may change at any time with or without notice

** Required Qualifications*
* + BS or MS degree in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with relevant experience of 8+ years for BS or 3+ years for MS.

+ Extensive cell culture experience with solid knowledge of cell biology principles.

+ Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.

+ Detail oriented with good organizational skills and documentation practices.

+ Ability to work effectively, independently, as well as part of a team.

+ Knowledgeable in process and analytical development, phase appropriate technology transfer, process comparability and qualification, process monitoring and GMPs, ICH, ISPE, and BPE guidelines.

+ Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others.

+ Able to work flexible hours including working in weekends.

+ This position requires on-site work.

** Preferred Qualifications*
* + Deep knowledge and experience with various human cell culture platforms, especially in human pluripotent stem cell culture and differentiation processes towards products for regenerative medicine

+ Experience in cell/gene therapy GMP manufacturing, scale-up/scale-down

+ Proficiency in using Microsoft Office software (Excel, PowerPoint, Word), common lab instrument

+ Direct experience in process characterization, development of process control strategy, process qualification and validation

** Location and Working Environment*
* + This position is based in Westborough, MA, USA and will require on-site work.

** 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.

** Our 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 contribution.

** Salary Range*
* $94,570-$135,100 (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…