Senior Bioprocess Associate
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Job Detail
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Offered Salary 0
Job Description
Great opportunity to be part of a dedicated team building capability to serve the rapidly expanding gene therapy market. Vector BioMed aims to become a leading supplier of high-quality Lentiviral vectors for research and clinical use. You will leverage your expertise in bioprocessing to ensure the efficient and compliant manufacture of viral vectors in pre-clinical and GMP manufacturing in a dynamic new company setting. This position requires a deep understanding of viral vector production processes, hands-on experience with bioprocess equipment, and the ability to mentor junior staff.
Ideal Candidate
- Works as part of a Team responsible for the frontline manufacture of Vector BioMed’s lentiviral vectors (LVV) and plasmids for research, pre-clinical and clinical products in GLP and GMP compliant setting.
- Approaches work with a detail-oriented mindset.
- Collaborates and contributes by providing input into activities such as training, procedure writing, troubleshooting, equipment and room cleaning, batch/lab record execution and finalization, deviation investigation and closure, change controls and CAPA effectiveness.
- Strives for excellence to ensure on-time execution of processes while continuously improving in quality and efficiency.
- Performs daily activities in compliance with cGxPs, SOPs and applicable guidelines.
Key Responsibilities:
- Process Execution
- Oversee and execute lentiviral vector production processes, including cell culture, vector production, purification, and formulation.
- Operate and maintain bioreactors, filtration systems, and other bioprocessing equipment.
- Perform critical in-process testing and troubleshooting to ensure adherence to quality standards.
- Process Optimization
- Analyze process data to identify trends and areas for improvement.
- Implement process improvements to enhance yield, purity, and efficiency.
- Work collaboratively to scale-up and transfer processes to manufacturing.
- Compliance and Documentation
- Ensure compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and internal Standard Operating Procedures (SOPs).
- Maintain accurate and detailed records of processes, equipment usage, and batch production.
- Support preparation and review of GMP documents.
- Team Leadership and Training
- Mentor and train junior bioprocess associates.
- Provide guidance and support to ensure adherence to best practices and safety protocols.
- Lead and participate in cross-functional project teams to address production challenges and drive improvements.
- Problem-Solving and Troubleshooting
- Address and resolve production issues in real-time to minimize downtime and ensure product quality.
- Conduct root cause analysis for deviations and implement corrective and preventive actions (CAPAs).
- Continuous Improvement
- Stay current with industry trends and advancements in lentiviral vector manufacturing.
- Contribute to the development and refinement of new manufacturing technologies and methodologies.
- Preclinical Materials Ordering and Inventory Management
- Oversee the ordering and procurement of raw materials, reagents, and consumables required for bioprocessing.
- Monitor and manage inventory levels to ensure an uninterrupted supply of materials.
- Coordinate with suppliers and vendors to ensure timely delivery and quality of materials.
- Maintain accurate inventory records and manage material handling processes.
- Collaborate with Materials Handling team to forecast material needs and optimize inventory.
- Equipment Ownership and Maintenance
- Take ownership of critical bioprocessing equipment, ensuring it is properly maintained, calibrated, and validated.
- Troubleshoot and resolve equipment malfunctions and coordinate with service providers for repairs as needed.
- Maintain detailed equipment records, including maintenance logs, calibration data, and operational history.
Basic Qualifications
- Education: Bachelor’s degree in Science or Engineering
- Experience:Â Minimum of 5 years in bioprocessing/cell and gene therapy or a related field, with emphasis on upstream and/or downstream viral vector manufacture in Biotech/Pharma cGMP.
- Skills:
- Proficiency in upstream and/or downstream bioprocessing equipment and techniques, including cell culture, chromatography, filtration, and aseptic final fill.
- Strong understanding of GMP, regulatory requirements, and quality systems.
- Experience in materials ordering, procurement, and inventory management.
- Proven track record in equipment maintenance and ownership.
- Excellent problem-solving skills, data analytics, and attention to detail.
- Proven ability to work effectively in a team environment and mentor junior staff.
- Strong written and verbal communication skills.
- Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).
Preferred Qualifications
- In-depth knowledge of lentiviral vector production and purification processes.
- Proficient in system set up, control system operation and data collection.
- Experience with single-use systems and materials.
- Interested in cross-training to perform Allstream functions (both upstream and downstream operations)
- Strong interpersonal skills, solid skills in mathematics, communications, and organization.
- Presentation skills.
Physical Requirements
- Ability to move 50 lbs.
- Ability to work in a laboratory and GMP manufacturing environment, which may involve standing for extended periods, handling chemicals, and working with biological materials.
What we Offer
- Competitive salary commensurate with experience
- Benefits package including health insurance, retirement plans, and paid time off
- A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology.
- Exceptional opportunities for learning and growth
- On-site gym membership
Apply Now
Application ends in 14d 34min