Astellas Pharma Manufacturing Support Specialist II in Westborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma 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.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
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 Marlborough, Massachusetts.
Astellas is announcing a Manufacturing Support Specialist II opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
As a member AIRM's Manufacturing Technical Support (MTS) team, the Manufacturing Support Specialist will play a critical role in the maintenance and management of Manufacturing's training program, technology transfer program and quality management system. These major job functions include the responsibility to drive change controls, deviations, and CAPAs to completion as well as implement continuous improvements to AIRM's training and tech transfer programs through analysis of Key Performance Indicators (KPIs).
Essential Job Responsibilities:
Maintains training program for manufacturing processes and procedures
Ensures all manufacturing personnel are maintaining training requirements for GMP compliance
Propose changes/modifications to training program based on new technology/process requirements
Implements training content in various formats including but not limited to instructor-led, self-paced web-based, virtual/distance-learning, and other computer-based technologies
Establishes learning effectiveness measurement strategies for various change efforts
Maintains training tracker to allow for complete visibility to departments on manufacturing personnel training status
Provide input on medium and high-level deviations (Investigations)
Support Change Controls as related to Manufacturing -- New Product Introduction, New Technology introduction, Process Change, etc.
In collaboration with QA, monitor KPIs.
Technology Transfer (20%):
Maintain the technology transfer program, supporting site and corporate objectives to deliver programs per established timelines.
Lead and execute technology transfers from MS&T to MFG.
Coordinate tech transfer deliverables from MS&T to MFG.
BA/BS degree with 3+ years or MS with 0-2 years of related experience
Knowledge in risk management and risk documentation
Experience using a variety of instructional delivery methods and media including face-to-face, virtual, and web-based learning.
Strong oral, written communication and interpersonal skills
Bachelor's Degree in Quality, Manufacturing, Information Systems, Business or Engineering, education, training, communication, organizational development or related discipline
2+ years of experience in Quality or Manufacturing environment (pharmaceutical or medical device industry preferred)
Understanding of change management and project management methodologies
Proficiency utilizing MS Office products and basic statistical software
Detail oriented with good organizational skills and documentation practices.
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.
Experience with continuous improvement and/or operational excellence (OpEx) is highly desirable.
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans