Job Description
Position Summary:
Join a growing team as a key member in the Manufacturing department where you can see the end result of your contributions benefit patients' lives. As a Downstream Pilot Plant Associate, you play an integral role in ensuring the on-time delivery of quality Gene Therapy products. You will participate in diverse activities including downstream process execution, maintaining GLP documentation, operating and maintaining process equipment, authoring records and procedures, and supporting continuous improvement efforts for manufacturing viral vector gene therapy.
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.
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.
Pay ranges between $75-84/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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