DOWNSTREAM MANUFACTURING ASSOCIATE I

Downstream Manufacturing Associate I

Location: Pennington, New Jersey

Category: Manufacturing

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description Pay range: 20-28/hr

• depending on experience

Position Overview

The Downstream Manufacturing Associate I is responsible for supporting day-to-day downstream manufacturing operations in a cGMP cleanroom environment. This position assists with purification and processing activities including buffer preparation, chromatography operations, filtration processes, equipment setup, cleaning, and aseptic manufacturing activities while maintaining compliance with GMP requirements.

Key Responsibilities

Downstream Manufacturing Operations

• Prepare buffers and process solutions according to approved procedures and batch records.
• Support chromatography operations including column packing, column preparation, and system setup.
• Perform filtration operations including depth filtration, tangential flow filtration (TFF), and sterile filtration.
• Execute product pooling, sampling, and material transfers.
• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.

Purification Processing

• Assist with chromatography processes.
• Support UF/DF operations using TFF systems.
• Operate single-use flow paths and associated downstream equipment.
• Perform process monitoring activities under supervision.

Documentation & Compliance

• Complete batch records, logbooks, and GMP documentation accurately and contemporaneously.
• Follow SOPs, batch records, and work instructions.
• Report deviations, equipment issues, and atypical events to supervision.
• Support internal audits and inspection readiness activities.

Continuous Improvement

• Participate in training and qualification programs.
• Support process improvement and operational excellence initiatives.
• Assist with manufacturing readiness activities.

Qualifications Education & Experience

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.
• High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.

Required Skills

• Basic understanding of biologics purification and downstream processing.
• Ability to follow detailed manufacturing procedures.
• Strong attention to detail and documentation practices.
• Effective communication and teamwork skills.
• Knowledge of cGMP requirements is preferred.

Preferred Skills Experience with:

• Chromatography systems
• Tangential Flow Filtration (TFF)
• Buffer preparation
• AKTA chromatography platforms
• Single-use technologies
• Aseptic processing

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

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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.