![Cellares](https://media.trabajo.org/img/noimg.jpg)
Manager, Quality Control
2 months ago
Position Summary
We are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.
This is a multidisciplinary role & this individual will further interface across many parts of the company to support novel products used in the cell and gene therapy world. This role will be a hands-on resource reporting to the Director of Quality Control.
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.
Responsibilities
- Schedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samples
- Ensure the quality control lab is held to GxP standards and safety standards
- Create, review and approve Certificate of Analysis
- Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
- Review and approve data to ensure accuracy and regulatory compliance
- Collaborate with QC Microbiology management in establishing specifications and justification of specifications
- Create, review and approve new and revision of analytical test methods
- Create, review and approve method validation protocols/reports and other documentation such as analytical reports
- Create, review and approve stability protocols and reports
- Create, review and approve quality control operation procedures
- Manage the validation of analytical methods used in QC as well as the transfer and validation of methods to contract testing laboratories
- Manage training of other analysts to perform laboratory procedures and assays
- Participate in internal assessments and audits as required
- Manage stability program
- Serve as Quality Control representative during cross-functional/project meetings
- Serve as subject matter expert between Quality Control and other departments, vendors, or contractors
- Behave as a working backup QC analyst for testing activities as needed
- Support Quality Systems such as Change Control, Deviation, CAPA, Audits, Quality Metrics
- Manage and grow a phase appropriate team of Quality Control personnel
- Establish user requirements for purchase of new Cellares GMP lab equipment
- Manage equipment validation, calibration, maintenance, and troubleshooting
- Assemble and report contract laboratory testing data
- Assist in the preparation of dossiers and data packages in support of Cellares' products for regulatory agencies
- Other duties as assigned
Requirements
- Bachelor's degree in a science discipline required, or comparable experience. Master's degree in a scientific discipline is preferred
- 7+ years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
- At least 2 years in a managerial role
- Prior experience related to method development/validation
- Strong background in cell biology, immunology, and molecular biology
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
- Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
- Identifying, authoring, and supporting OOS, DRs, and CAPAs
- Equipment IQ/OQ/PQ experience
- Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
- Excellent interpersonal, verbal, written communication and organization skills
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
- Must be able to commute to South San Francisco
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company's Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
-
South San Francisco, California, United States pliant-therapeutic Full timePliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the...
-
Manager/Senior Manager, Supplier Quality
2 months ago
South San Francisco, California, United States Allogene Therapeutics Full timeAbout Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...
-
San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries,...
-
Manager, Quality Control
3 weeks ago
San Diego, California, United States Avidity Biosciences, Inc Full timeAvidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases.We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies...
-
Manager/ Senior Manager Quality Assurance
2 weeks ago
San Francisco, California, United States Nurix Therapeutics Full timeManager/ Senior Manager Quality Assurance This Manager/Senior Manager in Quality Assurance will lead the electronic Quality management system (eQMS) and compliance activities for product development and commercialization efforts. This person will work closely with QA Operations and other functional groups to ensure a timely flow of information and...
-
San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries,...
-
Quality Inspector
3 weeks ago
South San Francisco, California, United States Aerotek Full timeQUALITY INSPECTORTEXT FOR INTERVIEW:PETER Description:Provides the necessary quality inspection skills to support the Company in achieving optimal levels of safety, quality, productivity, and delivery to assure internal and external customer success.Operates CMM's for First Piece Inspection and Production ApprovalReads drawings to determine specifications...
-
Quality Inspector
4 weeks ago
South San Francisco, California, United States Aerotek Full timeDescription:Provides the necessary quality inspection skills to support the Company in achieving optimal levels of safety, quality, productivity, and delivery to assure internal and external customer success.Operates CMM's for First Piece Inspection and Production ApprovalReads drawings to determine specifications and tolerances for a variety...
-
Manager Integrity Risk Acquirer Controls
3 weeks ago
San Francisco, California, United States Visa Full timeJob DescriptionEcosystem Security & Integrity (ESI) is a Global Risk group that is tasked with the role of upholding the security and integrity of the payment ecosystem through the interdiction of illegal and fraudulent activity. This is achieved through the deployment of risk quality control and/or compliance programs. The programs are deployed through Visa...
-
GxP Supplier Quality Contractor
4 weeks ago
South San Francisco, California, United States American Cybersystems, Inc. Full timeInnova Solutions is immediately hiring for a GxP Supplier Quality Contractor Position type: Full time Contract. Duration: 12 months Location: South San Francisco, CA As a GxP Supplier Quality Contractor, you will: Job Description: Main Purpose of the Position Support External Quality GxP Supplier Quality Managers in the following key aspects of their...
-
Sr. Quality Documentation Specialist
6 days ago
San Francisco, California, United States Michael Page Full timeEquity Competitive comp, great leadership, great hours About Our Client My client is a leader in the health and wellness industry, dedicated to providing high-quality products that promote well-being and healthy living. Our commitment to excellence is reflected in our innovative product offerings and our adherence to the highest standards of quality and...
-
Controller
1 month ago
San Francisco, California, United States Hex Full timeExciting Opportunity:Join our team at Hex and be a part of transforming the way data work is done. Hex is a leading platform that enhances analytics workflows, making them more potent, collaborative, and shareable. With a global user base, Hex is known for its exceptional user interface, innovative features, and unparalleled flexibility, loved by users...
-
Senior Director of Clinical Quality Assurance
1 month ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance...
-
Ramp Tower Controller
4 weeks ago
San Francisco, California, United States United Airlines Full timeThere's never been a more exciting time to join United Airlines. We're on a path towards becoming the best airline in the history of aviation. Our shared purpose – Connecting People, Uniting the World – is about more than getting people from one place to another. It also means that as a global company that operates in hundreds of locations around the...
-
Controller
3 weeks ago
San Francisco, California, United States Afresh Full timeAfresh is on a mission to eliminate food waste and make fresh food accessible to all. Our first A.I.-powered solution optimizes ordering, forecasting, and store operations for fresh food departments in brick-and-mortar grocers. With our Fresh Operating System, regional and national grocery retailers have placed $1.6 billion in produce orders across the US...
-
Technical Operations Control
3 weeks ago
San Francisco, California, United States Paramount Full timeKPIX is looking for a skilled full-time Ingest/Transmission operator. The Ingest/Transmission Operator oversees all inbound and outbound media, content, and news gathering. Responsibilities include monitoring on-air product quality, ensuring compliance with government regulations, troubleshooting equipment, and preparing programming for broadcast....
-
SFHN Chief Quality Officer 0943 Manager VIII
2 weeks ago
San Francisco, California, United States City and County of San Francisco Full timeJob DescriptionUnder general administrative direction, The SFHN Chief Quality Officer has oversight and responsibility for all Quality Management related activities throughout the SFHN. The SFHN includes Zuckerberg San Francisco General Hospital & Trauma Center, Laguna Honda Hospital & Rehabilitation Center and Ambulatory Care that includes Primary Care,...
-
Tech Risk and Controls Lead
2 weeks ago
San Francisco, California, United States JPMorganChase Full timeJob Description Join our team to play a pivotal role in mitigating tech risks and upholding operational excellence, driving innovation in risk management. As a Tech Risk & Controls Lead in Corporate Sector, you will be responsible for identifying, and mitigating compliance and operational risks in line with the firm's standards. You will also provide subject...
-
Senior Manager, Statistical Programming
2 weeks ago
South San Francisco, California, United States pliant-therapeutic Full timePliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the...
-
Tech Risk and Controls Senior Associate
1 week ago
San Francisco, California, United States JPMorganChase Full timeJob Description Join our dynamic team to navigate complex risk landscapes and fortify technology governance, making a pivotal impact in our firm's robust risk strategy.As a Tech Risk & Controls Senior Associate in Corporate Sector and Risk & Controls, you will take charge of the design, implementation, and upkeep of controls and risk management frameworks....