117 applicants
Cellares · 1 week ago
Senior Process Engineer
Bridgewater, NJ
Full-time
Onsite
Senior Level
$90K/yr - $210K/yr
5+ years exp
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Responsibilities
Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies
Work as the MSAT representative on client projects
Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers
Lead and drive technology adoption program initiatives, including ROI analyses with internal and external stakeholders
Support 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 systems
Perform manufacturability assessments for new process introductions
Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS
Work with our software team to provide feedback on internal software solutions
Provide technical leadership to Manufacturing and other departments associated with GMP operations
Assess all major deviations including those that impact product quality. Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
Maintain and report process run summaries, and continued process verification reports
Prepare and present data associated with manufacturing processes to internal and external partners
Support for process qualification and validation preparation, execution, and reporting
Work with clients on process mapping of the manufacturing processes
Other duties as assigned
Qualification
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Required
Bachelor’s Degree in a scientific or related field is required
A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
Experience in the Pharma/Biotech industry in technology transfer
Must 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 site
Adherence 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 actions
Relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plus
Must have experience writing, reviewing and approving GMP documentation
Self-motivated and passionate about advancing the field of cell therapy
Self-awareness, integrity, authenticity, and a growth mindset
Desire 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.
Benefits
Medical, Dental, and Vision Plans
401(k) Matching
Free EV Charging
Onsite lunches
Stock options
Company
Cellares
Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.
51-200 employees
H1B Sponsorship
Cellares has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$355MKey Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M
Leadership Team
Fabian Gerlinghaus
Co-Founder and CEO
Omar Kurdi
Co-Founder and President
Recent News
2024-05-20
2024-05-20
Company data provided by crunchbase
