We are seeking a Manufacturing Associate position based at to our new GMP Manufacturing site in Norwood, MA.
The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. He/she will apply existing and new knowledge of bio-process unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. They will be able to operate pilot-scale bio-processing equipment and interact fluidly with peers and supervisors in the Pilot Plant, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts.
location: Norwood, Massachusetts
job type: Contract
salary: $36.33 - 42.74 per hour
work hours: 3 to 11
- Demonstrate general knowledge of standard laboratory practices and equipment.
- Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Complete tasks in support of large scale manufacturing, including in the care of high-value capital equipment, such as pilot-scale chromatography systems.
- Assist in the investigation of procedural deviations.
- Practice safe work habits and adhere to safety procedures and guidelines.
- Utilize knowledge to improve operational efficiency.
- Adhere to Pilot Plant gowning procedures and maintain a clean general operating area.
- Adhere to documented waste handling procedures to respect environmental regulations.
- Bachelor's Degree
- 0-2 years of experience in a GMP manufacturing environment.
- Ability to document and communicate technical and operational observations clearly and efficiently
skills: CAPA, GMP (Good Manufacturing Practice), Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.