Manufacturing Associate

Integrated Resources Inc.; West Chester (Chester County); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in strategic workforce solutions is seeking a Manufacturing Associate for its new biologics manufacturing facility. This role involves hands-on purification operations, documentation development, and compliance with Good Manufacturing Practices. Ideal candidates have a background in biology or chemistry, and experience in cGMP environments.

Qualifications

• 2-4 years of experience in cGMP manufacturing.
• 3-5 years hands-on experience with Purification equipment.
• Experience with buffer solution preparations.

Responsibilities

• Contribute to downstream operations including TFF and column chromatography.
• Develop procedures for Manufacturing Downstream group.
• Assist in troubleshooting equipment or process issues.

Skills

Analytical skills

Aseptic technique

Strong communication skills

Education

Associate degree in biology, chemistry or related area

Tools

TrackWise

Purification equipment

Job 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 biologics 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.

· Practice a continuous improvement mindset by making suggestions on process improvements.

Qualifications

· At minimum, an Assoc. degree in biology, chemistry or a related scientific or technical area.

· 2 to 4 years of experience within cGMP manufacturing.

· Ability to work in fast paced, dynamic environment.

· 3-5 years hands on experience with Purification equipment such as columns, TFF, filling.

· 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.

· Experience with process development, tech transfer and optimization a plus.

· Strong understanding of cGMP’s as applicable to biologic operations.

· Good analytical skills to interpret and understand purification equipment and data.

· Excellent oral and written communication skills.

· Ability to stand, walk, bend and reach for long periods of time.

· Ability to work flexible working hours.

· Effectively manages time and must pay attention to detail.

· Ability to lift and push up to 30 pounds or more.

· Must be able to read, interpret, and follow SOP’s, batch documents and other procedures.