Manager, Quality Control

United States·BridgewaterFull Timemid

OtherQuality Control

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Overview

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 Bridgewater, NJ.

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OtherQuality Control

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 Bridgewater, NJ. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.

This individual will lead a group of QC analysts performing analytical testing of in-process and final product from cell therapy products. They will interface across different parts of the company to support novel products used in cell and gene therapy. This role will report to the Senior 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.

Schedule/Manage routine and non-routine analysis of in-process, 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

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

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

BA or B.S. degree in a science discipline required, or comparable experience; M.S. in a scientific discipline is preferred

Minimum of 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 preferred

Strong background in cell biology, immunology, and molecular biology and associated analytical assays

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

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.