Manager, Quality Control

Cellares•Bridgewater, NJ

1d•$90,000 - $210,000•Onsite

About The Position

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.

Requirements

BA or BS degree in a science discipline required, or comparable experience; MS 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

Responsibilities

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