Manufacturing Upstream Associate I/II

Kashiv BioSciences, LLC•Piscataway, NJ

19h•$30 - $38•Onsite

About The Position

The Manufacturing Upstream Associate is a hands-on position responsible for manufacturing operations that executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian-based biosimilars. Responsible for executing cell culture batches from 50L to 2000L volumes within a current Good Manufacturing Practice (cGMP) environment. Responsibilities such as preparation media/buffers, filtration, aseptic procedures biosafety cabinet and bioreactor operations, and cell removal filtration. This position also requires responsibilities such as preparation media/buffers, filtration, aseptic procedures biosafety cabinet and bioreactor operations, and cell removal filtration.

Requirements

High school diploma or equivalent required.
Familiarity with safety protocols/procedures
Ability to work in a team-oriented environment with cross-functional groups.
Ability to work in a fast-paced environment and handle changing manufacturing demands.
Proficient in MS Word, Excel, and PowerPoint.
Excellent written and verbal communication skills. Ability to communicate technical details at all levels, including senior leadership.
Ability to troubleshoot technical issues and propose short- and long-term solutions.
Strong time-management skills and the ability to work under demanding timelines.

Nice To Haves

Bachelor’s degree preferred.
Experience in a manufacturing environment or 1-2 years of relevant experience preferred.
General working knowledge with disposable bioreactors, filtration, depth filtration, and single use consumable technologies such as bags, tube sets, and manifolds.
Hands-on experience with mammalian cell culture and/or media preparation tasks in biopharma or biotech manufacturing setting.
Proficiency in aseptic operations and in-process sampling.
Experience in supporting cGMP operations and commercial exposure is a plus.

Responsibilities

Demonstrate a sound knowledge and understanding of cGMP requirements. Adhere to real-time documentation during production run and maintain accurate records/logs.
Set up, operate, and break down upstream equipment including bioreactors, depth filtration, and disposables.
Perform upstream processes at multiple scales in a cGMP environment.
Perform calculations for processing, weighing materials, chemical and reagent additions.
Uses programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment.
Work with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
Follow all GMP instructions in the manufacturing area and take responsibility / ownership of environmental health and safety policies.
Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
Comply with all company policies and standards. Ensuring all operations comply with cGMP, safety, and data integrity standards.
Performs other functions as required or assigned.
Revision of solution preparation batch records, SOPs, Protocols and logbooks.
Providing support during quality audits and regulatory inspections.
Order, maintain, track, and staging of raw materials and consumables for upstream, downstream, and media/buffer preparation processes.
Perform label verification, receipt checks, and electronic inventory updates.
Coordinate with warehouse and planning teams for material readiness.
Managing material inventory inside cleanroom areas.