Position Summary & Role
The Manufacturing Department performs small and large operations, including but not limited to Cell Culture, Purification, MFG Support and Drug Product Manufacturing activities in our Marlborough Facility. This is a day shift position including holidays and weekends.
This is an exciting opportunity to contribute to the buildout and qualification of a new manufacturing facility for viral vectors and vaccines, establishing a state of the art manufacturing operation.
Job Responsibilities
Responsible for assisting with startup activities in area of responsibility.
Assists in commissioning & qualification of production equipment.
Assists in the review & creation of operation documents by providing input to technical composition of documents.
Operates on the manufacturing floor in accordance with cGMP's and standard operating procedures.
Prepares equipment for manufacturing operations and monitors equipment to ensure process specifications are met.
Uses and maintains bench top equipment in accordance with relevant procedures.
Effectively demonstrates understanding of cGMPs & applies to specific responsibilities.
Follows accurate oral & written procedures when operating production equipment & performing processing steps.
Maintains orderliness of process area.
Practices safe work habits and adheres to Resilience's safety procedures and guidelines.
Assists in training of new and junior staff.
Utilizes manufacturing knowledge to improve process operations and affect positive change.
Escalates issues related to product and safety to senior staff.
Preferred Experience, Education & Qualifications
High School Diploma/GED and 3+ years in cGMP manufacturing environment or Bachelor's degree and 2+ years experience
Ability to lift a minimum of 40 lbs
Ability to stand for 6 hours in a production suite
Ability to gown and gain entry to manufacturing areas
Ability to work weekends, including holidays as scheduled
Other Ideal Personal Characteristics:
Associate's or Bachelor's Degree - Life Sciences
Familiarity with Manufacturing Control Systems (i.e. Delta V)
Experience with Gene Therapy operations
Facility startup experience
Training experience
Experience reviewing and creating controlled documents