Massachusetts Jobs

Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)

• Care Deeply – for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Within MA-TC Manufacturing Science and Technology (MS&T) team, the successful candidate will be integral to executing all routine operations including process optimization, manufacturing process monitoring and technical support, and technology transfer for cell therapy products. The candidate will work closely within the team and across functional groups to ensure smooth transition of new cell therapy products and processes from process development into GMP manufacturing, and execution of technical training of MFG personnel.

Responsibilities

Initiate and maintain lab activities/inventory required for technology transfer & technical training of MFG personnel.

• Perform new technology evaluation and process optimization/scale up to improve GMP production.

• Participate in technology transfer from CMC Development Groups or other Astellas sites to GMP operations including technical training to others.

• Support manufacturing department activities including training MFG associates, supporting MBR development and review, trending key process parameters across manufacturing batches.

• Perform routine laboratory experiments to support MS&T activities.

• Manage laboratory equipment to ensure proper operation & maintenance.

• Ability to execute protocols and summarize results independently.

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

• Interact closely with multiple interdisciplinary groups including Manufacturing, Quality Assurance, Quality Control, Process Development, and

Required Qualifications

• BS or MS degreein biology, bioengineering, or related scientific field with relevant experience of 4+ years for BS & 2+ years for MS in a biotechnology, cell therapy or pharmaceutical industry.

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

• Proficient at small to medium-scale process development with excellent aseptic and drug product/substance manufacturing process.

• Experience with cGMP manufacturing, process automation, and technology transfer preferred.

• Able to develop, revise, and review SOPs, protocols, batch records, process development and technical reports.

• Excellent written and verbal communication skills with strong collaboration/ team building and organization skills.

• Detail oriented with strong planning and organization skills.

• Able to manage priorities and maintain timelines for multiple projects in afast-pace setting.

• Ability to work effectively independently, as well as part of a team*

Preferred Qualifications

• Hands-on experience with human Embryonic Stem cells (hESCs), human induce Pluripotent Stem Cells (hiPSCs), and their differentiation.

• Knowledge and direct experience in technical transfer and/or GMP manufacturing process and good documentation practices and lifecycle management.

• Knowledge and experience in process development and/or characterization of biologics and/or cell therapy manufacturing process with cellular and molecular assays.

Able to work flexible hours including weekends.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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

• Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans