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Cellares Corporation
South San Francisco, CA, United States
Position Summary We are seeking an innovative and highly motivated Senior Process Specialist to join the 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 the development, process transfer, compliance, and scalabi
Job Source: Cellares CorporationFreenome
San Francisco, CA, United States
Why join Freenome? Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the
Job Source: FreenomeCellares
South San Francisco, CA, United States
Position Summary This position is responsible for supporting the activities involved in analytical process transfers, compliance, and scalability for Cellares' Quality Control (QC) operations. This individual will focus on technology transfers from Analytical Development (AD) to support ongoing GMP QC operations, as well as driving and developing
Job Source: CellaresMichael Page US
Oakland, CA, United States
About Our Client Our client is a leading manufacturer of close tolerance metal-cutting machine tools for turning, milling, and grinding as well as additive manufacturing. They are regionally recognized for their impressive track record of quality fabrication and innovative process techniques. With a rich history spanning 65 years, they have establi
Job Source: Michael Page USCellares
San Francisco, CA, United States
Position Summary This position is responsible for supporting the activities involved in analytical process transfers, compliance, and scalability for Cellares’ Quality Control (QC) operations. This individual will focus on technology transfers from Analytical Development (AD) to support ongoing GMP QC operations, as well as driving and developing a
Job Source: CellaresPage Southerland Page, Inc.
San Francisco, CA, United States
Overview: At Page, we promise design that makes lives better. Were actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the world. We credit the success of our projects that build communities to the global diversity of
Job Source: Page Southerland Page, Inc.Q Bio
San Carlos, CA, United States
Q Bio is building technology for the Physical of the Future that measures more, faster and cheaper about the human body, to enable proactive primary care for all. We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole-body scanning technology, that highlights the most important changes in a p
Job Source: Q BioHargrove Engineers & Constructors
Martinez, CA, United States
Who We Are Hargrove supplies unparalleled services in engineering, procurement, construction management, and technical services in the industrial, commercial, and government sectors. With over 2,000 Teammates across the US, we build long-term support relationships in the energy generation, manufacturing, research and development, and process-heavy
Job Source: Hargrove Engineers & ConstructorsAlameda, CA, United States
GeneFab is seeking a highly motivated Process Engineer III / Sr. Process Engineer, Manufacturing Sciences and Technology to lead and support internal/external technology transfers and process support activities with high-level technical expertise from development into GMP manufacturing. This role will be responsible for overseeing and facilitating the transfer of new processes and technologies from developmental stages to manufacturing scale, ensuring seamless integration and optimal performance. The ideal candidate should be experienced in cell and gene therapy (autologous and allogeneic) processes and cGMP operations, and comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities. The candidate must collaborate effectively with cross-functional teams including Manufacturing Sciences and Technology, Supply Chain, QC, PD, AD, and Quality Assurance, as well as the Client to accomplish deliverables for GMP readiness.
Key Responsibilities: Technology Transfer Management Lead technology transfer projects, coordinating with cross-functional teams including Process Development and external partners.
Develop and implement technology transfer plans, ensuring adherence to timelines and quality standards.
Conduct risk assessments and development mitigations strategies for technology transfer activities.
Lead technology transfer discussions between sending units (Process Development and external partners) and receiving units (Manufacturing, QA, QC, SC, AD).
Responsible for authoring Manufacturing process descriptions, engineering protocols, technical reports, and material specifications. Reviewing and approving manufacturing batch records and any other relevant document to support successful transfer.
Create feasibility/gap assessments and facility fit analysis for new products and processes.
Key Responsibilities: Process Optimization & Continuous Improvement Evaluate manufacturing processes and identify areas for improvement. Propose and implement innovative solutions to enhance process robustness and scalability.
Implement process enhancements to increase efficiency, reduce costs, and improve product quality.
Participate in continuous improvement initiatives within MSAT and Manufacturing departments.
Supervise/conduct lab work to resolve investigations and/or to demonstrate proof-of-concept for proposed changes.
Key Responsibilities: Manufacturing Process Support Support process deviation investigations, root cause analyses, and CAPAs.
Train manufacturing staff on new processes and technologies.
Qualifications: Bachelor’s or Masters in a relevant field (e.g., Engineering, Biotechnology, Molecular Biology).
A minimum of 5-7 years of relevant experience in biopharmaceutical process engineering, with a focus on cell and gene therapy.
Proven experience in technology transfer, process development, and GMP manufacturing.
Experience with viral vector manufacturing, cell therapy, and mRNA is a plus.
Strong communication and project management skills, with a commitment to cross functional collaboration.
Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance.
Basic understanding of lifecycle management of clinical and commercial manufacturing processes.
Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner.
$125,000 - $155,000 a year Salary is DOE About GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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Process Engineer III / Senior Process Engineer, MSAT jobs in Alameda, CA, United States
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