Manufacturing Associate - Sun-Thurs 2nd shift
Company: Hornet Staffing
Location: Norwood
Posted on: March 20, 2023
Job Description:
Description:
- Company 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
Company.
- 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 Company'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 Company.
- 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
Keywords: Hornet Staffing, Boston , Manufacturing Associate - Sun-Thurs 2nd shift, Other , Norwood, Massachusetts
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