Pilot Plant Associate Chromatography, ultrafiltration

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

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 - or text - or you can share the updated resume at com

Additional Information :

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

Remote Work :

Employment Type :

Contract

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 exp...