Downstream Manufacturing Associate I

Planet Pharma; Pennington (NJ); On-site; USD 28,000 - 39,000; Full time

Job summary

Planet Pharma is seeking a Downstream Manufacturing Associate I in Pennington, NJ to support day-to-day downstream operations in a cGMP cleanroom. Responsibilities include buffer prep, chromatography setup, filtration, material transfers, and equipment maintenance.

The role requires following GMP documentation and batch records, with attention to detail and strong teamwork. Educational paths include a STEM degree with relevant experience or a higher school diploma with extensive biopharma

Qualifications

• Bachelor’s degree in biotechnology or related field with 0–2 years of experience, or HS diploma with 4+ years’ biopharma experience.
• Strong understanding of biologics purification and downstream processing.
• Proficiency in following detailed manufacturing procedures and GMP documentation.

Responsibilities

• Prepare buffers and solutions per batch records.
• Support chromatography operations including column packing and system setup.
• Perform filtration operations including TFF and sterile filtration.
• Execute product pooling, sampling, and material transfers.
• Maintain equipment setup, cleaning, and routine maintenance.

Skills

Biologics purification

Downstream processing

Documentation practices

Teamwork / communication

cGMP knowledge

Education

Bachelor’s degree in Biotechnology/Biochemistry/Chemical Engineering/Life Sciences

HS Diploma/GED with 4+ years biopharma manufacturing experience

Tools

AKTA chromatography platforms

Single-use technologies

Tangential Flow Filtration (TFF)

Chromatography systems

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.