Downstream Manufacturing Associate

Job Description

Downstream Manufacturing Associate Opportunities (Associate I & Associate III/Lead)

Location: Pennington, NJ

Schedule: Onsite

Duration: 6-Month Contract with Potential for Extension or Conversion

Important Scheduling Requirement

This role offers a dynamic manufacturing environment, and candidates should be open to occasional schedule flexibility, including overtime, evenings, overnights, weekends, or holidays as production needs require.

Position Overview

We are seeking Downstream Manufacturing professionals at both the Associate I and Associate III (Lead) levels to support biologics manufacturing operations in a cGMP environment. These roles are responsible for executing and/or leading downstream processing activities, including buffer preparation, chromatography, filtration, equipment operation, GMP documentation, troubleshooting, and manufacturing readiness.

Candidates with varying levels of experience are encouraged to apply. Final leveling will be determined based on qualifications, technical expertise, and leadership experience.

Key Responsibilities

Downstream Manufacturing Operations

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• Prepare buffers and process solutions according to approved procedures and batch records.
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• Support or lead chromatography operations, including column packing, column preparation, and system setup.
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• Perform or oversee filtration activities, including depth filtration, tangential flow filtration (TFF), UF/DF, viral filtration, and sterile filtration.
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• Execute product pooling, sampling, and material transfers.
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• Operate single-use flow paths and associated downstream manufacturing equipment.
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• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.
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• Monitor critical process parameters and ensure adherence to process specifications.
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• Troubleshoot process and equipment issues to support successful batch execution.
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Purification Processing

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• Support or lead purification activities including Protein A capture, ion exchange chromatography, viral inactivation, UF/DF, and final bulk drug substance processing.
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• Operate chromatography skids, AKTA systems, TFF platforms, filtration equipment, and other downstream processing technologies.
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• Support process monitoring and manufacturing optimization activities.
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• Assist with manufacturing readiness and campaign execution.
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Documentation & Compliance

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• Complete batch records, logbooks, and GMP documentation accurately and contemporaneously.
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• Follow SOPs, batch records, and work instructions.
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• Report deviations, equipment issues, and atypical events.
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• Support or lead deviation investigations, CAPAs, change controls, and risk assessments.
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• Maintain inspection readiness and compliance with GMP requirements.
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• Participate in audits, regulatory inspections, and manufacturing documentation review activities.
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Cross-Functional Collaboration

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• Partner with Manufacturing, QA, QC, MSAT, Validation, Engineering, Facilities, Warehouse, and Supply Chain teams.
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• Support technology transfer activities, process validation, PPQ campaigns, and commercial manufacturing operations.
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• Participate in continuous improvement and operational excellence initiatives.
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Leadership & Development (Associate III/Lead)

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• Provide technical leadership and shop-floor support during manufacturing operations.
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• Coordinate manufacturing campaigns and purification schedules.
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• Serve as a primary technical resource for downstream manufacturing activities.
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• Train, mentor, and develop junior manufacturing personnel.
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• Support onboarding, qualification programs, scheduling, and personnel development.
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Qualifications

Associate I

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• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.
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• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.
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• Basic understanding of biologics purification and downstream processing.
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• Strong attention to detail and ability to follow manufacturing procedures.
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• Knowledge of cGMP requirements preferred.
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Associate III (Lead)

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• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience.
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• Previous lead operator, project coordination, or manufacturing leadership experience preferred.
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• Strong understanding of biologics manufacturing, GMP requirements, and manufacturing systems.
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• Proven troubleshooting, decision-making, and cross-functional leadership capabilities.
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Preferred Experience

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• AKTA chromatography systems
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• Protein A and polishing chromatography
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• Tangential Flow Filtration (TFF)
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• UF/DF operations
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• Viral filtration and sterile filtration
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• Buffer preparation
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• Single-use technologies
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• Aseptic processing
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• Technology transfer activities
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• Process validation and PPQ campaigns
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• CAPA and deviation management
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• Commercial biologics manufacturing
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• Regulatory inspections and client audits
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• Lean Manufacturing and continuous improvement initiatives
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Physical Requirements

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• Ability to stand for extended periods.
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• Ability to bend, reach, and lift up to 50 pounds.
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• Ability to work in cleanroom environments while wearing required PPE.
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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

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.