Upstream Manufacturing Associate II

Upstream Manufacturing Associate II

Location

Pennington, New Jersey

Category: Manufacturing

Salary

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Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

Pay range: 25-35/hr

*depending on experience

Position Overview

The Upstream Manufacturing Associate II independently executes upstream manufacturing operations in a cGMP cleanroom environment. This role requires technical expertise in mammalian cell culture, bioreactor operations, harvest processing, and in-process testing while serving as a mentor to junior associates and supporting process improvements.

Key Responsibilities

• Upstream Manufacturing Operations

• Independently execute media and buffer preparation activities.

• Perform cell culture expansion, vial thaw, seed train operations, and production-scale bioreactor processing.

• Operate and monitor fed-batch and perfusion bioreactor systems.

• Execute harvest, filtration, and process transfer operations.

• Troubleshoot manufacturing and equipment issues within established procedures.

• In-Process Monitoring

• Perform routine process monitoring and data review.

• Operate analytical equipment including:

• o Cedex Cell Analyzer

• o Blood Gas Analyzer (BGA)

• o Osmometer

• o pH and conductivity meters

• Aseptic Processing & Compliance

• Perform aseptic operations in classified environments.

• Maintain GMP-compliant documentation.

• Participate in deviation investigations and root cause assessments.

• Support audit preparation and inspection activities.

• Training & Continuous Improvement

• Train and mentor Associate I personnel.

• Assist with SOP revisions and manufacturing documentation updates.

• Participate in process improvement and operational excellence initiatives.

• Support technology transfer and manufacturing readiness activities.

Qualifications

• Education & Experience

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 3-5 years of relevant biopharmaceutical manufacturing experience.

• High School Diploma/GED with 6+ years of relevant experience may be considered.

• Required Skills

• Strong understanding of mammalian cell culture and upstream processing.

• Experience operating bioreactors and associated equipment.

• Knowledge of GMP manufacturing requirements.

• Strong analytical and troubleshooting skills.

• Effective communication and team collaboration abilities.

• Preferred Skills

• Experience with:

• o Single-use bioreactor systems

• o Perfusion technologies

• o Cell culture analytics

• o Process troubleshooting

• o Technology transfer activities

• Physical Requirements

• Ability to stand for extended periods.

• Ability to bend, reach, and lift up to 50 pounds.

• Ability to work in cleanroom environments while wearing required PPE.

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

• Fraud Alert

• Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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