Senior Quality Assurance Specialist, Cellares
$90-210k
+ Stock options
Cell therapy manufacturing services provider
Open for applications
Cell therapy manufacturing services provider
201-500 employees
Open for applications
$90-210k
+ Stock options
201-500 employees
Company mission
To accelrete access to life-saving cell therapies.
Role
Who you are
- This individual is detail-oriented and proactive
- 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
- Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc)
- 5-8 years of experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc)
- Strong knowledge with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
- Team player who can operate independently, with strong focus on safety, quality and timelines
- Excellent communication, organizational, and analytical skills in a fast-paced, dynamic environment
- Strong attention to detail and commitment to ensuring high standards of quality and compliance
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
What the job involves
- We are seeking a talented and passionate Senior Quality Assurance Specialist to play a vital role in ensuring the quality and compliance of our product
- In this position, this hire will collaborate with various departments, including manufacturing, R&D, and engineering to review documentation, conduct/host audits, investigate deviations and lead projects
- Provides dedicated QA support to client projects and client interactions & meetings; involved from inception of a client’s project until project closure
- Supports Clinical QA activities, including initial process development and non-clinical batch production
- Monitor day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for cGxP integrated contract manufacturing facility
- Ability to troubleshoot, identify process pathways, and develop improvement strategies for site teams on projects/issues
- Understand advanced topics pertaining to cGMP
- Participate in regulatory inspections or customer audits as required
- Understand and articulate company business strategy, maintaining a broad view of the business and recognizing changes and trends
- Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
- Compile lot genealogy and lot disposition packages, driving lot disposition activities to ensure timely product release
- Provide oversight to product status, including preparation of documents for shipping activities
- Oversee the quality tag-out system
- Actively participate in and approve deviation investigations, utilizing Root Cause Analysis tools for effective and timely closure
- Ensure correct implementation of CAPA based on deviations raised and ensure timely closure of CAPA
- Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
- Support changeover activities and QA on call
- Provide training to new members and manufacturing teams
- Provide quality oversight for operations document changes (e.g., MBRs, SOPs, forms, logbooks, etc)
- Provide quality change request oversight for process and operation changes
- Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections
- Revise, review, and approve SOPs, protocols, reports, and records
- Perform any other tasks as assigned
Our take
There is a significant need for efficient, scalable manufacturing of cell therapies in the biopharmaceutical industry. As demand for advanced treatments like CAR T-cell therapies rises, traditional manufacturing methods often struggle with scalability, high costs, and process failures, limiting patients' access to these lifesaving therapies.
In response, Cellares has developed the CEll Shuttle platform, an automated system designed for high-throughput cell therapy production. The Cell Shuttle can manufacture 16 batches simultaneously, cutting batch costs by up to 50%. By integrating advanced technologies for flow cytometry and cell sorting, Cellares enhances operational efficiency, providing comprehensive solutions that accelerate access to therapies.
Partnering with industry leaders like Kite, Bristol Myers Squibb, and Cabeletta Bio further strengthens its market position, showcasing the platform's potential impact. Along with over $355M in funding and a commercial-scale facility in New Jersey, Cellares is well-prepared to scale operations and meet global demand, positioning itself for future growth in the evolving cell therapy landscape.
Steph
Company Specialist at Welcome to the Jungle
Insights
44% employee growth in 12 months
Company
Funding (last 2 of 3 rounds)
Aug 2023
$255m
SERIES C
May 2021
$82m
SERIES B
Total funding: $355m
Company benefits
- Holidays & Flexible Vacation
- Parental Leave
- Comprehensive Healthcare
- 401k + Company Match
- Catered Onsite Meals
- Premium Technology
- EV Charging
- Professional Development
Company HQ
The East Side, South San Francisco, CA
Leadership
Fabian Gerlinghaus
(Co-Founder & CEO)Graduated from the University of Munich with a Master's Degree in Aerospace Engineering. Prior to co-founding Cellares in 2019, they were the CHief Innovation officer at Synthego.
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