Pilot Plant Associate - Chromatography, ultrafiltration

VTekis Consulting LLP

Pilot Plant Associate - Chromatography, ultrafiltration

San Diego, CA
Full Time
Paid
  • Responsibilities

    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

  • Qualifications

    Additional Information

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