Job Title: Senior Technician/Associate, Manufacturing
Job Number: 25460
Location: Smithfield, RI
The Sr. Technician/Manufacturing Associate is a shift team member for a new cell therapy manufacturing process and a delegate for the Manufacturing Senior Associate. This individual will be expected to support the successful tech transfer and ongoing manufacturing of our clinical pipeline. They will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance. They will ensure all processes and procedures related to operations are in full accordance with good manufacturing practices, code of federal regulations, site quality systems and company policies. This individual may also perform complex activities outside of routine manufacturing operations.
- Establish a first in class safety culture through identification of potential safety hazards and implementation of effective controls. Drive a culture of zero lost time injuries within the team through the rapid reporting/resolution of unsafe conditions.
- Author and update manufacturing procedures to ensure manufacturing activities can be executed right first time
- Execute all aspects of the process from media/buffer preparation, vial thaw, cell culture, harvest, and final aseptic filling.
- Maintain all manufacturing areas in a perpetual state of compliance and inspection readiness.
- With guidance from supervisor, defines and successfully executes new continuous improvement initiatives
- Provide effective written or verbal communication to peers, senior associates, and area management within their operational group
- Support the cleaning and waste management process of the production suites
- Must be committed to the development of team members and have a team first mindset
- Demonstrates strong knowledge in all relevant areas of cell therapy manufacturing and single use technologies
- Has a sound understanding of cGMP with an appreciation for operational discipline
- Ability to multi-task and work within a fast-paced environment
- Excellent oral and written communication skills
- Has desire and is effective at leading other staff members to build knowledge within the group
- Minimum B.S. degree in biochemistry, bioengineering, or related technical field or 2 years of experience in biopharmaceutical based GMP manufacturing operations with no degree
- Proven track record of operating in a biologics or cell therapy manufacturing facility
- Work Hours: 12 hour rotating shift. Requires overtime to work evenings, weekends or holidays, as required to meet production timelines.
- Travel is expected to be <10%
EEO Statement: Rubius Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.