Full-Time
Senior Quality Control Analyst
Posted on 12/20/2024
Cellares
201-500 employees
Develops and manufactures cell therapies
Compensation Overview
$90k - $210k/yr
Senior
Bridgewater Township, NJ, USA
Candidates must be able to commute to Bridgewater, New Jersey.
- Bachelor's degree in a science discipline required, or comparable experience
- 5+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred
- Prior experience related to method development/validation
- Prior experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency and other cell therapy related assays is preferred
- Knowledge of pharmaceutical cGMP (US and EU) is preferred
- Must have excellent verbal, written, interpersonal, and organizational and communication skills
- Must be able to commute to Bridgewater, New Jersey
- Excellent verbal, written, organizational, presentation and interpersonal skills
- Self-awareness, integrity, authenticity, and a growth mindset
- Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples
- Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.)
- Perform timely and accurate peer review of analytical test results/reports
- Prepare COA/COT for testing performed
- Identify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2
- Initiate and investigate deviations related to quality control
- Compile and review data to ensure accuracy and regulatory compliance
- Support development for specifications and justification of specifications
- Participate in validation and technical transfer of analytical methods commensurate with experience
- Write and revise test methods
- Maintain required training and training records and provide training to qualify other associates
- Participate in internal assessments and audits as required
- Support equipment validation, calibration, maintenance, and troubleshooting
- Write method validation protocol/reports and other documentation such as test reports
- Write stability protocol and stability reports
- Write and revise Quality Control Standard Operating Procedures
- Supply Quality Control data necessary for regulatory submissions
- Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc
- Assist in general upkeep of the laboratory and maintain a clean work environment
- Perform other duties as assigned
- 5+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred
- Prior experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency and other cell therapy related assays is preferred
- Knowledge of pharmaceutical cGMP (US and EU) is preferred
Cellares develops and manufactures cell therapies, focusing on biotechnology. The company operates as an Integrated Development and Manufacturing Organization (IDMO), which means it combines the development and manufacturing processes of cell therapies in one facility. This approach is different from traditional Contract Development and Manufacturing Organizations (CDMOs) that keep these processes separate. Cellares utilizes its proprietary "Smart Factory" technology, featuring an automated single-use cartridge system that significantly boosts productivity, reduces costs, and lowers process failure rates. The company serves a variety of clients, including those in preclinical, clinical, and commercial stages, and has partnered with major pharmaceutical companies to enhance the manufacturing of CAR-T cell therapies. Cellares aims to provide efficient and cost-effective manufacturing solutions for cell therapies, making it a competitive choice in the biotechnology sector.
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.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Company Match
Stock Options
Growth & Insights and Company News
6 month growth
↑ 2%1 year growth
↑ 2%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).