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Astellas Pharma Manufacturing Support Specialist II in Westborough, Massachusetts

Manufacturing Support Specialist II

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 of 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 Manufacturing Support Specialist II opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

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:

Training (40%):

  • 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

Quality (40%)

  • 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.

  • Execute and eventually lead cross functional risk assessments

  • Propose and implement site continuous process improvements projects

  • Ability to draft technical reports

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.

  • In collaboration with MFG and MS&T, develop and monitor KPIs for reporting.

Organizational Context:

  • Directly reports to the Senior Manager of Manufacturing Technical Support

Qualifications:

Required:

  • 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

Preferred:

  • 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 devical 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.

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 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

#LI-LK

Category GMP Technical Operations

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

EOE including Disability/Protected Veterans

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