We are seeking a cGMP Manufacturing Associate for the Personalized Cancer Vaccines. This position will be based in our new GMP Manufacturing site in Norwood, MA.
The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based personalized cancer vaccines 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 Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts.
This is a 6 month, contract position.
location: Norwood, Massachusetts
job type: Contract
salary: $25.50 - 30.00 per hour
work hours: 9 to 5
- Produce mRNA Personalized Cancer Vaccines
- Execute manufacturing operations using disposable technologies, automation and Manufacturing Execution Systems (MES)
- Develop batch records, SOPs and training materials for startup of the Norwood Facility
- Closely partner with QA peers for rapid disposition of personalized cancer vaccines
- Demonstrate general knowledge of standard manufacturing 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.
- 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 gowning procedures and maintain a clean general operating area.
- Adhere to documented waste handling procedures to respect environmental regulations.
- Bachelor's Degree in Biology, Chemistry, Chemical engineering, Bio-mechanical engineering, Bio-engineering, Biomedical engineering, Biochemistry or related field, Associates with 4+ years related experience or 5+ years of related GMP experience
- 2-4+ years of experience in a GMP manufacturing environment.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
- Exceptional written, oral communication, and organizational skills required
skills: GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
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.