Senior Bioprocess Associate

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 CandidateWorks 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 ExecutionOversee 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 OptimizationAnalyze 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 DocumentationEnsure 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 TrainingMentor 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 TroubleshootingAddress 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).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 ManagementOversee 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 MaintenanceTake 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 QualificationsEducation:

Bachelor’s degree in Science or EngineeringExperience:

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 QualificationsIn-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.Physical RequirementsAbility 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 OfferCompetitive salary commensurate with experienceBenefits package including health insurance, retirement plans, and paid time offA bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology.Exceptional opportunities for learning and growth

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