Pilot Plant Associate - Chromatography, ultrafiltration

Qualifications

· B.S. degree in biology or related area with 4-6 years of experience working in process development or Manufacturing support in bioprocessing required

· Hands on experience with Chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience.

· Good manufacturing practices required

· Good documentation practices required

· Ability to effectively collaborate with team members

· Experience with manufacturing investigations for biologics manufacturing.

· Familiarity with Quality systems and Enterprise Resource Planning etc.

Responsibilities (Essential Role Responsibilities):

· Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration and depth filtration, at pilot and production scales.

· Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units.

· Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities.

· Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements.

· Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting.

· Ensure compliance with company SOPs, training requirements, and scale-up best practices.

· Maintain facility readiness and support regulatory inspections through vigilant oversight.

· Utilize Quality Systems and ERP platforms to document and track manufacturing activities.

· Drive process improvements through the change control process or other initiatives.

· Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities.

· Provide process subject matter expertise and take ownership of assigned deliverables.

· Preferred: Experience conducting manufacturing investigations in biologics production.

· Demonstrate strong technical writing and communication skills.

· Maintain a safe working environment and stay current with all assigned training.

Position Requirements (Required and/or Preferred Skills, Experience and Education):

Regards,

Mohammed Ilyas,

PH - 229-264-4024 or text - 229-469-1455 or you can share the updated resume at Mohammed@vtekis. com

All your information will be kept confidential according to EEO guidelines.