Downstream Manufacturing Specialist

Astrix Inc.; Morrisville (NC); On-site; USD 114,616,000 - 121,229,000; Full time

Job summary

Astrix Inc. in Morrisville, NC is seeking a Downstream Manufacturing Specialist to support gene therapy product manufacturing in a GMP environment. This contract-to-hire role focuses on executing downstream purification and processing while ensuring quality and compliance.

You will work closely with Manufacturing, QA, Process Development, and Facilities to optimize processes, perform sampling, document results, and participate in deviations, CAPAs, and tech transfer as needed.

Qualifications

• Bachelor's degree in a relevant scientific/engineering discipline.
• 2+ years of biopharmaceutical GMP manufacturing experience.
• Hands-on experience with downstream bioprocessing and purification.
• Ability to follow SOPs and batch records with high accuracy.

Responsibilities

• Execute downstream manufacturing activities for gene therapy products per batch records and GMP.
• Perform purification and processing steps including chromatography, TFF, and filtration.
• Operate, clean, sanitize, and maintain manufacturing equipment.
• Document activities in batch records and electronic systems with GDP.
• Support deviations, CAPAs, and change controls.
• Work cross-functionally with QA, Process Development, Engineering, and Facilities.
• Participate in shift activities and occasional weekend work.

Skills

Downstream bioprocessing

GMP manufacturing

SOPs & batch records

Cross-functional teamwork

Education

Bachelor's degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related field

Job description

We are seeking a Downstream Manufacturing Specialist to support the manufacturing of gene therapy products in a GMP-regulated environment. This role will be responsible for executing and supporting downstream purification and processing activities, ensuring manufacturing operations are performed safely, efficiently, and in accordance with approved procedures and regulatory requirements.

The ideal candidate has hands‑on experience with downstream bioprocessing, strong attention to detail, and a working knowledge of GMP manufacturing practices. This is a contract-to-hire opportunity for an individual who is interested in building a long‑term career within a growing gene therapy organization. Pay rate: $40-42/hr Shift: 1st shift, with occasional 2nd shift

Key Responsibilities

• Execute downstream manufacturing activities for gene therapy products in accordance with approved batch records, SOPs, protocols, and GMP requirements.
• Perform and support downstream purification and processing operations, which may include:
  • Clarification and filtration
  • Centrifugation
  • Chromatography
  • Tangential flow filtration (TFF)
  • Buffer and media preparation
  • Ultrafiltration/diafiltration
  • Product concentration and formulation
  • Aseptic processing and final bulk operations
• Operate, clean, sanitize, and maintain manufacturing equipment and associated systems.
• Perform in‑process sampling and coordinate with Quality Control for testing as required.
• Accurately document manufacturing activities in batch records, logbooks, and electronic systems in accordance with Good Documentation Practices (GDP).
• Identify process deviations, equipment issues, and manufacturing abnormalities and promptly elevate them to appropriate personnel.
• Support deviation investigations, CAPAs, change controls, and other manufacturing quality initiatives.
• Follow all applicable GMP, environmental health and safety (EHS), biosafety, and facility procedures.
• Assist with equipment setup, line clearance, cleaning verification, and manufacturing area preparation.
• Participate in process optimization, continuous improvement, and manufacturing scale‑up activities.
• Work closely with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, and Facilities teams.
• Support technology transfer and process validation activities as needed.
• Maintain a clean, organized, and compliant manufacturing environment.
• Participate in shift activities, overtime, and occasional weekend work based on manufacturing schedules.

Qualifications

Required

• Bachelor's degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or a related scientific/engineering discipline, or equivalent relevant experience.
• 2+ years of experience in biopharmaceutical, biologics, cell therapy, gene therapy, or related GMP manufacturing.
• Hands‑on experience with downstream bioprocessing and purification operations.
• Understanding of GMP manufacturing principles and Good Documentation Practices.
• Ability to follow detailed SOPs and batch records while maintaining a high level of accuracy.
• Strong communication, organizational, and problem‑solving skills.
• Ability to work effectively in a cross‑functional, team‑oriented environment.
• Ability to work on‑site in a manufacturing environment and wear required PPE.