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Form of workJob Description
*** is seeking a cGMP Manufacturing Associate for mRNA Manufacturing of Personalized Cancer Vaccines based at our GMP Manufacturing site in Norwood, MA. These are shift positions within PVU Manufacturing at ***.
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 bioprocess 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 bioprocessing 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. The anticipated initial time frame for this contract role is six months.
Here s What You ll Do:
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 *** s 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.
Here s What You ll Bring to the Table:
Bachelor s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field with 0-2 years, Associates with 2-4 years related experience or 5+ years of related GMP experience and/or 2-3 years in a GMP environment at ***.
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
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 bioprocess 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 bioprocessing 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. The anticipated initial time frame for this contract role is six months.
Here s What You ll Do:
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 *** s 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.
Here s What You ll Bring to the Table:
Bachelor s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field with 0-2 years, Associates with 2-4 years related experience or 5+ years of related GMP experience and/or 2-3 years in a GMP environment at ***.
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
