Manufacturing Associate II
Company: Integrated Resources, Inc
Location: Cambridge
Posted on: January 27, 2023
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Job Description:
Client is seeking a Manufacturing Associate for Specialty Small
Molecule Manufacturing. This position is located at our research
labs in Cambridge, MA. The shifts are Monday-Friday 1st shift from
7:30 am to 3:30 pm and 2nd shift from 3:00 pm to 11:00 pm. (All new
hires will report to Norwood or Burlington or Cambridge, location
to be confirmed with new hire, Mon-Fri 1st shift for the first few
weeks to allow for training before moving to Cambridge.)
The individual in this role will be part of a cohesive team
responsible for producing custom small molecule materials to enable
manufacturing of mRNA-based medicines for evaluation in human
clinical trials. He/she will apply existing and new knowledge of
process chemistry 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 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.
Heres What Youll Do:
Execute manufacturing operations using disposable technologies,
automation, and Manufacturing Execution Systems (MES) to produce
small molecule constructs to support production of mRNA
products.
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 Clients 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.
Heres What Youll Bring to the Table:
Bachelors Degree in Biology, Chemistry, Chemical engineering,
Biomechanical engineering, Bioengineering, Biomedical engineering,
Biochemistry or related field with 2-5 years experience or 7+ years
of related GMP experience
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: Integrated Resources, Inc, Cambridge , Manufacturing Associate II, Other , Cambridge, Massachusetts
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