Downstream Manufacturing Associate – Gene Therapy

WhiteCap Search; San Diego (CA); On-site; USD 55,000 - 83,000; Full time

Job summary

WhiteCap Search is seeking a hands-on specialist to support technical operations and manufacturing activities for gene therapy programs in a pilot/manufacturing environment in San Diego, CA. The role emphasizes downstream purification, equipment operation, batch records, and compliance with cGMP practices.

The ideal candidate brings 4 years' bioprocessing experience, working on chromatography, TFF, and depth filtration, with strong documentation and cross-functional teamwork abilities in a

Qualifications

• Bachelor's degree in biology, biochemistry, biotechnology, chemical engineering or related field.
• Approximately 4 years of experience in bioprocessing, biologics manufacturing, or related environment.
• Hands-on downstream processing experience including chromatography, ultrafiltration/TFF, and depth filtration.
• GMP-regulated environment and good documentation practices.

Responsibilities

• Execute downstream purification processes at lab, pilot, and manufacturing scale.
• Operate and maintain bioprocessing equipment used in downstream manufacturing.
• Prepare and maintain batch records, SOPs, and other manufacturing documentation.
• Support technology transfer and scale-up activities as programs progress.
• Collaborate with cross-functional teams on deviations, investigations, and corrective actions.
• Identify opportunities for process and operational improvements.
• Maintain a safe, compliant manufacturing environment.
• Document manufacturing activities using electronic systems.
• Serve as a technical resource for manufacturing processes and deliverables.
• May lead specific manufacturing operations on the floor.

Skills

Bioprocessing

Downstream purification

GMP compliance

Documentation practices

Cross-functional teamwork

Technical writing

Education

Bachelor's degree in Biology/Biochemistry/Biotechnology/Chemical Engineering

Tools

Chromatography

Ultrafiltration/TFF

Depth filtration

Job description

A growing biopharmaceutical organization is seeking a professional to support technical operations and manufacturing activities for gene therapy programs. This individual will be hands‑on within a pilot/manufacturing environment, supporting downstream purification activities, equipment operation, manufacturing documentation, process troubleshooting, and continuous improvement initiatives. The role is well suited for someone with experience working in bioprocessing or biologics manufacturing who is comfortable working directly on the manufacturing floor.

Key Responsibilities

About the Opportunity

A growing biopharmaceutical organization is seeking a professional to support technical operations and manufacturing activities for gene therapy programs. This individual will be hands‑on within a pilot/manufacturing environment, supporting downstream purification activities, equipment operation, manufacturing documentation, process troubleshooting, and continuous improvement initiatives. The role is well suited for someone with experience working in bioprocessing or biologics manufacturing who is comfortable working directly on the manufacturing floor.

Key Responsibilities

• Execute downstream purification processes at laboratory, pilot, and/or manufacturing scale, including chromatography, ultrafiltration/tangential flow filtration (TFF), and depth filtration.
• Operate and maintain bioprocessing equipment used in downstream manufacturing.
• Perform manufacturing activities in accordance with cGMP and good documentation practices.
• Prepare and maintain manufacturing documentation, including batch records, SOPs, equipment/logbook documentation, reports, and other technical records.
• Support technology transfer and scale‑up activities as programs progress.
• Partner with Manufacturing, Quality, Process Development, and other cross‑functional groups on deviations, investigations, root‑cause analysis, troubleshooting, and corrective actions.
• Identify and implement opportunities for process and operational improvements.
• Support manufacturing readiness and maintain a high level of compliance within the production environment.
• Document manufacturing activities using electronic quality and business systems.
• Serve as a technical resource for assigned manufacturing processes and deliverables.
• Participate in on‑floor activities and may serve as a lead for specific manufacturing operations.
• Maintain a safe, compliant, and organized manufacturing environment.
• Complete required training and maintain adherence to applicable procedures and policies.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific/engineering discipline.
• Approximately 4 years of experience in bioprocessing, biologics manufacturing, process development, or a related environment.
• Hands‑on experience with downstream processing, particularly:
  • Chromatography
  • Ultrafiltration/TFF
  • Depth filtration
• Experience working in a GMP‑regulated environment.
• Strong understanding of good documentation practices.
• Experience supporting manufacturing investigations, troubleshooting, or deviation activities within biologics or another regulated manufacturing environment.
• Familiarity with electronic quality systems and/or ERP platforms.
• Strong technical writing, communication, and organizational skills.
• Ability to work effectively with cross‑functional teams in a fast‑paced manufacturing environment.

Preferred Experience

• Experience with viral vector or gene therapy manufacturing.
• Experience supporting pilot‑scale or clinical manufacturing operations.
• Experience with manufacturing investigations and root‑cause analysis.
• Experience supporting technology transfer or process scale‑up activities.
• Experience working directly with external manufacturing or technical partners.

Work Environment

This is a fully onsite role in San Diego, CA, requiring regular hands‑on work within a manufacturing/pilot plant environment.

Contract Opportunity Details

6 months, with potential for extension. Start is set forLate August / Early September 2026

Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.