Manufacturing Associate, Downstream Processing

At Proclinical, we are seeking an individual to fill the role of Manufacturing Associate, Downstream Processing, Clinical Manufacturing, based in West Chester, PA. The Manufacturing Associate will contribute to the Downstream Manufacturing group, and 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 Teva's proprietary and biosimilar biologics pipeline.

Responsibilities

• Assist in developing procedures 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.
• Assist in troubleshooting equipment or process issues.
• Initiate and complete deviations change controls, investigations as assigned.
• Compliance to safety guidelines and current Good Manufacturing Practices (cGMP).
• Ability to lead the purification operations.
• Assist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs.
• Analyze in process samples generated from purification activities using all relevant equipment.
• Review manufacturing data as assigned.

Skills And Qualifications

• AA/AAS in related field and 2-5 years of relevant experience, including a cGMP environment, fermentation, process development, tech transfer and optimization.
• Experience with buffer solution preparations within a cGMP environment.
• Experience with TrackWise for performing change controls, deviations.
• Strong background in aseptic technique and microbial controls.
• Strong knowledge of software, including Microsoft Office Suite, process control SCADA software, single use systems, and UNICORN software.
• Experience with process development, tech transfer and optimization preferred.
• Good analytical skills to interpret and understand purification equipment and data.
• Strong written, verbal, and interpersonal communication skills.
• Ability to stand, walk, bend and reach for long periods of time.
• Ability to work flexible working hours.
• Ability to lift and push up to 30 pounds or more.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Corrin Pyle at (+1) 2674358555 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.