Job Description

ForDoz Pharma Corp., based in East Windsor, New Jersey, is a fully integrated pharmaceutical company specializing in conventional sterile injectables and complex formulations. With over 20 years of experience, ForDoz has advanced U.S. capabilities for manufacturing innovative injectable therapeutics to meet growing demand. Leveraging cutting-edge technologies like liposomal/nanoparticle-based drug delivery and controlled-release systems, ForDoz addresses challenges in sterile drug product development, such as prolonged circulation, reduced toxicity, and sustained release. The company is committed to excellence in sterile injectable quality and delivering solutions to address unmet medical needs.

Job Responsibilities

• Reporting to Vice President of Quality, the QC Director provides leadership and support in all aspects of analytical testing.
• The QC Director manages the analytical laboratory to meet testing requirements in support of site manufacturing and the development laboratory. This includes overseeing the operation of the QC chemistry and stability functions, QC microbiology, and analytical development.
• Provide strong leadership and guidance for laboratory operations and personnel
• Manages QC employees, including performance management, technical and leadership development, and succession planning of the analytical group
• Provides in-depth technical and scientific advice and guidance to laboratory personnel
• Ensure appropriate training is planned executed and documented for QC personnel
• Leads the development and maintenance of QC policies and SOPS
• Manages the validation of analytical methods used in manufacturing operations
• Leads the development and maintenance of specifications, reference standards, and retains programs
• Manages the performance of laboratory testing, review and release data for all raw materials, in process materials, and finished products
• Plans and executes QC testing to ensure agreed upon timelines are met, associated records are evaluated and data are accurate, valid and complete
• Ensures the technical compliance suitability for all testing is conducted appropriately
• Oversees the evaluation of new equipment for purchase and inclusion in the laboratory
• Ensures that all QC instruments have been qualified, are maintained in a qualified state, and subsequent PM and calibration programs are implemented
• Manages analytical technology transfer between R&D and CROs
• Ensures that the analytical group adheres to current FDA, ICH, and other foreign guidelines and regulations
• Maintains continuous improvement and performance management of direct reports to increase productivity and reduce quality risks
• Interacts with the FDA and other regulatory agencies worldwide regarding any questions relating to chemistry, microbiology and stability testing
• Provides support for product filings with regulatory agencies

Requirements

• Bachelor degree minimum in Chemistry or relevant field with 15 years’ relevant experience, a Master’s degree with 12 years’ relevant experience, or a Ph.D. with 10 year’s relevant experience.
• Minimum 5 years’ experience managing analytical scientists
• Significant experience with regulatory filings, USFDA ANDA preferred
• Strong quality background and focus
• Expertise in cGMP requirements
• Has good communication skills (both oral and written)
• Experience with injectable products is preferred
• Be able to work efficiently and handle multiple tasks simultaneously
• Has strong leadership skills
• Work hard and be a team player

**Please note this position is not eligible for employment visa sponsorship now or in future

Pay: 150,000 -$190,000 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics

Job Tags

Similar Jobs