Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
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.
Astellas is announcing a Senior Associate, MS&T opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. This is an onsite position.
Purpose:
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. The candidate will work closely within the team and across functional groups to ensure smooth transition of new products and processes from process development into GMP manufacturing, and execution of technical training of MFG personnel.
Essential Job 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, Facilities.
Organizational Context:
- Report directly to Director of Manufacturing Science and Technology (MS&T) or delegate
Required:
BS or MS degree in 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 a fast-pace setting.
Ability to work effectively independently, as well as part of a team
Preferred:
Knowledge and direct experience in various cell culture platforms including both adherent and suspension cell culture systems.
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.
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
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Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans