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Senior Process Engineer - Bridgewater, United States - Cellares
Description
Position SummaryWe are seeking an innovative and highly motivated Senior Process Engineer on our MSAT team who will contribute significantly to the development of our advanced cell therapy manufacturing platform.
This position is responsible for supporting the activities involved in development, process transfers, compliance, and scalability for Cellares' manufacturing operations.
This individual will focus on technology transfers from Process Development into GMP manufacturing facilities, as well as driving and developing process automation and scalability solutions to improve process reliability, safety, cost-effectiveness, scalability, and compliance.
This is a multidisciplinary role & this individual will interface across many parts of the company (with customers, scientists, researchers, and engineers) to develop the best solutions possible.
The successful candidate will be a resident expert in the areas of technology transfer and manufacturing science and technology.It is expected that this individual will work closely with other corporate functional areas and partners to ensure deliverables are met.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
ResponsibilitiesWork to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapiesWork as the MSAT representative on client projectsLead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customersLead and drive technology adoption program initiatives, including ROI analyses with internal and external stakeholdersSupport development of manufacturing operations including GMP system implementation and tasks related to GMP readiness Support process development and process comparability activities on Cellares technology as required Develop and review relevant SOPs for manufacturing operations and systemsPerform manufacturability assessments for new process introductionsDefine and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapiesWork with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMSWork with our software team to provide feedback on internal software solutions Provide technical leadership to Manufacturing and other departments associated with GMP operationsAssess all major deviations including those that impact product quality.
Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigationsMaintain and report process run summaries, and continued process verification reportsPrepare and present data associated with manufacturing processes to internal and external partnersSupport for process qualification and validation preparation, execution, and reportingWork with clients on process mapping of the manufacturing processesOther duties as assignedRequirementsBachelor's Degree in a scientific or related field is requiredA minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapyExperience in the Pharma/Biotech industry in technology transferMust know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.
Must comply with safety policies of the company and siteAdherence to cGMPs is required all times during the manufacture of Cell Therapy products.
All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actionsRelevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plusMust have experience writing, reviewing and approving GMP documentationSelf-motivated and passionate about advancing the field of cell therapySelf-awareness, integrity, authenticity, and a growth mindsetDesire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines.$90,000 - $210,000 a yearCellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
All displayed pay ranges are approximate, negotiable, and location dependent.
