KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements in the United States, Europe and Latin America. Werepresent clients in all industries and all sizes. Our mission is to provideexceptional client and candidate experiences in order to get the best possibleresults. On behalf of our client, we are excited to present the following confidentialrole. We look forward to hearing from you and discussing the opportunity!

The Role:

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The key accountability for this position is leading the downstream steps processing harvest from the bioreactor through to drug substance (Purification operations).

Key Responsibilities:

Lead the process team in daily manufacturing activities.

Coordinate the daily process schedule to ensure the daily processing is performed.

Ensure all necessary materials/supplies are staged for processing.

Perform daily process activities in compliance with standard operating procedures (SOPs) and execution of batch documents.

Operate downstream process equipment and operations in compliance with cGMP requirements (current good manufacturing practices).

Column chromatography

Virus filtration

Ultrafiltration/Diafiltration

Adjustment of intermediates

Other purification processing steps as needed.

Revise production batch records and appropriate SOPs.

Prepare equipment and solutions for processing.

Complete and review associated production records.

Complete cGMP documentation and logs.

Interact with Validation, Metrology, and Facilities groups to ensure equipment is maintained in cGMP status.

Prepare and submit samples for QC and other testing to the analytical laboratories.

Interact with Quality Assurance when compliance issues arise.

Support activities include maintaining supplies, preparing solutions, setting up and disassembling processing equipment cleaning and maintaining equipment, basic troubleshooting.

Follow safety and compliance procedures including training and ALCOA principles.

Participate on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Presentative Action.

Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive changes.

Work with manufacturing management to develop and maintain training materials and curricula on process operations, theory, and compliance.

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Requirements

High School diploma/GED, Biotechnology certificate or Associates degree in biology/chemistry with a minimum of 5 years of experience in cGMP manufacturing environment or a Bachelor's degree in biology/chemistry or a related discipline with a minimum of 3 years of experience in cGMP manufacturing environment.

Understanding of chromatography, membrane filtration and other unit operations used in protein purification.

Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.

The ability to cooperate with others in a team environment.

SOP writing.

Must have permanent US work authorization

Preferred Qualifications:

Proficiency in aseptic technique.

Experience using Unicorn AKTA skid or other manufacturing systems.

Experience with Athena or similar SAP system.

Benefits

Ourclient offers a comprehensive benefits package including:

401kMatching

Family andIndividual Insurance Packages (Health, Life, Dental, and Vision)

Paid TimeOff & Paid Holidays

Long &Short-Term Disability

IdentityTheft Plans

Retirement& Pension Plans

EmployeeAssistance Program

EmployeeReferral Program

TuitionReimbursement Programs

Advancement& Professional Growth opportunities 

ParentalLeave

& More

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$46k-62k (estimate)

POST DATE

03/09/2024

EXPIRATION DATE

07/02/2024

Overview of KP Recruiting Group

WEBSITE

kprecruiting.com

HEADQUARTERS

Minneapolis, MN

SIZE

<25

INDUSTRY

Business Services

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