ARD & QC Manager, Laboratory Operations

The ARD & QC Manager, Laboratory Operations will lead and manage various laboratory functions to ensure operational efficiency and regulatory compliance. Key responsibilities include the following:

• Equipment and software management
• Supervise, train, and mentor junior QC scientists and associate scientists
• Develop and implement corrective and preventive actions
• Chemical and consumables inventory management
• Internal safety and cGMP self-inspections
• Sample management, including outsourced testing
• EHS management

The incumbent works cross-functionally with internal departments and external resources on ARD/QC related issues. The ARD & QC Manager, Laboratory Operations, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities:

• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Lead and train quality control teams.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Serve as primary contact for negotiation of quotes, service agreements, and contracts
• Manage and schedule work outsourced to third-party analytical and metrology service providers.
• Develop procedures and SOPs for calibration and OQ of equipment
• Develop protocols for qualification/validation of software
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Manage lab chemicals and consumables including tracking and replenishing inventory.
• Lead internal self-inspections to ensure safety and cGMP compliance
• Prepare standard operating procedures (SOPs), protocols, reports, etc. as needed.
• Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
• Write deviations, change controls, and CAPAs, and/or assist management with these documents.
• Document work in laboratory notebooks and logbooks according to organizational GDP policies.

Required Skills and Abilities:

• Proficiency with Microsoft Office
• Knowledge and experience in cGMP, ICH guidelines, USP, and Ph.Eur.
• Hands-on experience with various analytical instruments.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfill the business need.

Education and Experience Requirement:

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• BS with at least 6 years of relevant experience, MS or higher degree with at least 4 years of relevant experience, or equivalent combination of work experience, education, and training.
• Must have at least 3 years of QC laboratory working experience.

Physical Demands

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds.
• Frequently requires the use of a step stool.
• Requires manual dexterity and visual abilities.

Working Condition:

Laboratory and office environment

Compensation:

$100,000-$130,000

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws