Pilot Plant Associate - Chromatography, ultrafiltration
Job Description
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
Additional Information
All your information will be kept confidential according to EEO guidelines.