Manufacturing Associate II

Company: Integrated Resources, Inc
Location: Cambridge
Posted on: January 27, 2023

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