Manufacturing Associate I–IV

Vita Global Sciences, a Kelly Company; Houston (TX); On-site; USD 78,000 - 94,000; Full time

Job summary

Kelly Scientific is partnering with a clinical-stage biotechnology company in Houston to manufacture gene therapy products and support clinical trials.

The Manufacturing Associate I–IV will operate equipment, purify viral vectors, prepare solutions, and ensure accurate documentation in a GMP cleanroom. Level determined by education and GMP background; 12-month assignment with day shift and occasional weekends.

Qualifications

• Bachelor’s degree in Biology, Biotechnology, or related field.
• GMP manufacturing experience preferred but not required.
• Experience in upstream and/or downstream manufacturing is a plus.
• Strong aseptic technique and contamination control.

Responsibilities

• Operate manual, semi-automated and automated equipment in support of production.
• Viral vector purification with process-scale chromatography equipment.
• Prepare buffer solutions and manage materials for production.
• Write and review SOPs and maintain documentation for quality systems.
• Assist validation, data collection, inventory management and maintenance of process equipment.

Skills

Aseptic technique

Documentation

GMP knowledge

Detail-oriented

Team collaboration

Education

Bachelor’s degree in Biology/Biotech

Tools

Single-use bioreactor systems

Cell culture

TFF

Biosafety cabinets

Viral vector purification

Job description

Job Title: Manufacturing Associate (I–IV)

Location: Houston, TX

Schedule: Day Shift; occasional weekend work may be required

Rate: ~$40/hr.

Duration: 12 months

About the Company

Kelly Scientific is partnering with a clinical-stage biotechnology company focused on developing life-changing genetic medicines for patients and families affected by rare neurological diseases.

Position Overview

We are seeking Manufacturing Associates (I–IV) to support the production of gene therapy products. The Manufacturing Associate will perform hands-on manufacturing activities supporting the production of preclinical and clinical biopharmaceutical products and help maintain a reliable supply of materials for ongoing clinical trials.

The level of the position will be determined based on the candidate’s relevant education, technical experience, and GMP manufacturing background.

Responsibilities

• Operation of manual, semi-automated and automated equipment in support of routine production of pre-clinical and clinical biopharmaceuticals
• Viral vector purification with process scale chromatography equipment
• Preparation of buffer solutions
• Staging of equipment and raw materials in production suites
• Assist in other production related activities such as validation, data collection, inventory management and maintenance of process equipment
• Perform cleaning of facility and unit process equipment
• Write and review SOPs and change control documents for manufacturing work areas
• Ensure proper documentation is completed to meet quality systems requirements
• Participate in facility safety programs
• Resolving technical problems via internal teams and external sources such as vendor support.

Additional responsibilities for advanced roles include:

• Authoring technical documentation such as summary reports.

Required Qualifications

Education

• Bachelor’s degree in Biology, Biotechnology, or a related scientific field.

Experience

• Biopharmaceutical manufacturing experience in a GMP-regulated environment is preferred but not required.
• Experience in upstream and/or downstream manufacturing processes are strongly preferred, including experience with:
• Single-use bioreactor systems
• Cell culture
• Aseptic processing and sterile operations
• Biosafety cabinets
• Tangential Flow Filtration (TFF)
• Buffer preparation
• Viral vector manufacturing or purification

Knowledge & Skills

• Working knowledge of cGMP requirements and regulated manufacturing environments.
• Understanding of complex manufacturing equipment and process instrumentation.
• Strong aseptic technique and attention to contamination control.
• Ability to accurately follow written procedures, protocols, and manufacturing instructions.
• Ability to develop or revise procedures when required.
• Comfortable performing repetitive laboratory/manufacturing tasks, including pipetting.
• Strong attention to detail and commitment to accurate documentation.
• Ability to communicate and collaborate effectively with personnel across multiple departments and levels of the organization.
• Ability to troubleshoot routine technical issues and elevate appropriately.

Cleanroom & Physical Requirements

• The majority of work will be performed in a GMP manufacturing cleanroom environment.
• Must be comfortable working in controlled environments, including areas operating up to ISO 5 / Grade A following appropriate training.
• Must be willing and able to follow gowning requirements, which may include coveralls, face masks, shoe covers, hair/beard nets, and other PPE.
• Ability to lift up to 50 lbs. with assistance.
• Work may involve exposure to high-pressure gases, flammable materials, cryogenic operations, and chemical hazards including strong acids and bases.
• Must consistently follow all applicable safety, environmental, and GMP procedures.