Full-Time
Senior Quality Validation Specialist
Confirmed live in the last 24 hours
Cellares
201-500 employees
Develops and manufactures cell therapies
Compensation Overview
$90k - $210k/yr
Senior
Bridgewater Township, NJ, USA
- Bachelor’s degree in a scientific or engineering discipline
- 5-8 years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
- 2+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations
- Excellent knowledge of the regulations for biologics, cell and gene therapy products
- Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is desirable
- Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
- Excellent understanding of risk management and CAPA processes
- Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
- Experience with computerized systems validation (CSV) is a plus.
- Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
- Author and maintain the IDMO Site Validation Plan
- Provide Quality oversight of process validation studies and process performance qualifications
- Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification & recertification, cleaning & sanitization, and facility controls
- Proactively identify & resolve technical and compliance issues/gaps
- Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge
- Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)
- Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
- Act as Quality Engineering Subject Matter Expert for responsible areas/projects during client or regulatory inspections
- Drive continuous improvement and increase efficiency and productivity
- Experience with on-site regulatory inspections is desirable
Cellares develops and manufactures cell therapies, focusing on streamlining these processes through its Integrated Development and Manufacturing Organization (IDMO) model. This approach combines development and manufacturing in one facility, unlike traditional methods that separate these functions. Cellares utilizes its proprietary "Smart Factory" technology, which features an automated single-use cartridge system, leading to a tenfold increase in productivity, a 50% reduction in costs per batch, and a 75% decrease in process failures. The company serves a diverse clientele, including preclinical, clinical, and commercial organizations, and has partnered with major pharmaceutical companies to enhance the manufacturing of CAR-T cell therapies. Cellares stands out from competitors by offering competitive pricing and improved efficiency, aiming to make cell therapy development and manufacturing more accessible and cost-effective.
Company Size
201-500
Company Stage
Series C
Total Funding
$355M
Headquarters
South San Francisco, California
Founded
2019
Simplify's Take
What believers are saying
- Partnership with Bristol Myers Squibb secures $380M for CAR T cell therapy manufacturing.
- Ossama Eissa's appointment as COO strengthens Cellares' global expansion and operational efficiency.
- Sony partnership enhances Cell Shuttle with advanced flow cytometry, improving precision and efficiency.
What critics are saying
- Emerging competition from bluebird bio may increase market pressure on Cellares.
- Rapid Smart Factory expansion could strain resources and affect quality control.
- Over-reliance on Bristol Myers Squibb partnership poses risk if dynamics change.
What makes Cellares unique
- Cellares' Cell Shuttle offers 10x scalability over manual cell therapy manufacturing processes.
- The Smart Factory technology integrates development and manufacturing, unlike traditional CDMOs.
- Cell Q automates QC for up to 6,000 batches, reducing manual labor and costs.
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6 month growth
↑ 1%1 year growth
↑ 3%2 year growth
↑ 5%bluebird bio announced on 21 February 2025 that it had entered into a definitive agreement to be acquired global investment firms Carlyle (DC, USA) and SK Capital (NY, USA) for US$3.00 per share in cash, plus a contingent value right of $6.84 per share if certain sales targets are met.
Cellares, a Bridgewater-based leader in automated cell therapy manufacturing, on Monday announced it appointed Ossama Eissa, former executive at Novartis, Lonza Biologics, and Legend Biotech, as chief operating officer.
Cellares, a Bridgewater-based leader in automated cell therapy manufacturing, on Monday announced it appointed Ossama Eissa, former executive at Novartis, Lonza Biologics, and Legend Biotech, as chief operating officer.Eissa’s extensive experience will support the expansion of Cellares’ Smart Factory network in the United States, Europe, Japan and other international markets, addressing the challenges of scalability, cost, and quality that have long hindered patient access. Through these advancements, Cellares will work to ensure that life-saving treatments are accessible for oncology and autoimmune patients globally.This appointment strengthens the Cellares leadership team in a time of rapid global expansion of the company’s IDMO manufacturing services, in response to the growing global demand for cell therapy manufacturing capacity.Eissa brings more than 20 years of experience in pharmaceutical and biotech manufacturing.He formerly served as vice president and general manager at Legend Biotech, where he led the Raritan production site through the global launch of Carvykti, a CAR-T cell therapy.At Lonza Biologics, Eissa managed Global Strategic Projects, contributing significantly to the Cell and Gene Technologies Business Unit by boosting manufacturing efficiency and driving commercial scale-up. He also oversaw U.S. manufacturing operations at Novartis, scaling production and supporting regulatory approval for Kymriah, the first FDA-approved CAR-T cell therapy.“Joining Cellares is an opportunity to address one of the biggest challenges in healthcare today: making cell therapies accessible to all of those who need them,” Eissa said. “The mission aligns closely with my experience in scaling complex manufacturing systems to benefit patients directly. I’ve witnessed the profound impact these treatments have, and I’m committed to ensuring that we reach more patients, especially those facing cancer and autoimmune diseases, with the reliability and speed they deserve.”
Self-acclaimed integrated development and manufacturing organization (IDMO) Cellares has partnered with Sony Corporation, a technology firm focused on the field of flow cytometry, to integrate advanced flow cytometry-based cell analysis and sorting solutions into the Cellares Cell Shuttle platform.
Cellares, a leader in cell therapy manufacturing and an Integrated Development and Manufacturing Organization (IDMO), has appointed Justin McAnear as Chief Financial Officer (CFO) and Jonathan Butler as General Counsel and Corporate Secretary (GC).