Purification Associate / Manufacturing Associate

Company Description

IRI believes in commitment, Integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.

Job Description

· The Manufacturing Associate will contribute to the Downstream Manufacturing group within the brand new state-of-the art biologic manufacturing facility.

· We are seeking a highly self-motivated person willing to contribute to the development, qualification, and eventual operation and overall success of downstream operations.

· This includes but is not limited to column packing, column chromatography and tangential flow filtration (TFF) and aseptic filling operations for proprietary and biosimilar biologics pipeline.

· Assist in developing procedures (SOP’s & Master Batch Records) for the Manufacturing Downstream group.

· Complete assigned tasks associated with Purification operations and assist in execution of operations such as column chromatography, TFF, CIP, column packing.

· Ability to work independently to develop and write documentation associated with Purification.

· Assist in troubleshooting equipment or process issues.

· Initiate and complete deviations, change controls, investigations, as assigned using TrackWise or any similar software system.

· Compliance to safety guidelines and current Good Manufacturing Practices (cGMP).

· Ability to train other associates and willing to be involved in cross-training in other groups, as required.

· Follow standard operating procedures.

· Ability to lead the purification operations.

· Assist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs such as IOQ and PQ.

· Ability to multi-task and work well with the team.

· Completes all training documentation within a defined time-frame.

· Analyze in process samples generated from purification activities by using pH/conductivity meters, scales, spectrophotometers etc.

· Performs review of the manufacturing documentation of the associated area.

· Other duties as assigned.

Additional Information

Regards,

Indu Dubey
Clinical Recruiter
732-844-8725 

indu @irionline.com