Downstream Manufacturing Associate

Astrix; Morrisville (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Join a dynamic team as a Manufacturing Process Technician, where you will play a crucial role in executing GMP manufacturing processes. This position offers the opportunity to ensure the consistent production of high-quality clinical materials while collaborating with cross-functional teams. Ideal candidates will have a strong foundation in biomanufacturing and a commitment to quality standards. If you're ready to contribute to innovative solutions in the pharmaceutical manufacturing industry, this role is perfect for you. Embrace the chance to grow in a supportive environment that values your skills and dedication.

Benefits

Medical insurance

Qualifications

• Experience in GMP biologics manufacturing is preferred.
• Familiarity with cGMP and GDP documentation standards is required.

Responsibilities

• Execute GMP manufacturing processes including upstream and downstream operations.
• Maintain compliance with cGMP, GDP, and internal quality policies.

Skills

cGMP compliance

FDA regulations

Effective communication

Team collaboration

Flexibility for varied shifts

Education

A.S. degree or Biomanufacturing certification

B.S. in Biochemistry or related field

Tools

Chromatography equipment

Analytical equipment

Job description

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This range is provided by Astrix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.00/hr - $42.00/hr

Direct message the job poster from Astrix

Scientific and technical staffing recruiter connecting top talent with leading companies

Position Summary:

The Manufacturing Process Technician is responsible for executing GMP manufacturing processes including upstream and downstream operations, material handling, and batch documentation. This role ensures consistent production of high-quality clinical materials and supports the successful transfer of new processes into manufacturing.

Contract (potential for conversion)

Multi-shift availability (1st and 2nd shifts)

Pay: $35–$42/hour

Looking for experience with AKTA

Key Responsibilities:

• Perform manufacturing operations from cell expansion through purification following MBRs and SOPs
• Prepare buffers and support solutions; pack, qualify, and clean chromatography columns
• Operate and maintain analytical and manufacturing equipment in cleanroom environments
• Edit and maintain SOPs, logbooks, and batch documentation in accordance with GDP
• Coordinate with supply chain on raw material delivery, cleaning, and stocking
• Support waste decontamination and removal following EHS standards
• Enter production data into databases and assist with batch closeout activities
• Ensure compliance with cGMP, GDP, CFRs, and internal quality policies
• Collaborate with cross-functional teams on tech transfers and troubleshooting production issues

Qualifications:

Required:

• A.S. degree, Biomanufacturing certification, or equivalent experience
• Familiarity with FDA regulations, cGMP, and GDP documentation standards
• Effective communication skills and ability to work collaboratively in a team
• Flexibility to work varied shifts including nights and weekends
• Ability to lift 25 lbs routinely and up to 50 lbs occasionally

Preferred:

• B.S. in Biochemistry, Bioengineering, Chemical Engineering, or related field
• 2+ years of GMP biologics manufacturing experience (e.g., cell culture, purification, aseptic fill/finish)
• Experience with single-use systems and GMP batch record management

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing and Research

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

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