ARD & QC Manager, Laboratory Operations

NJ Bio, Inc.; Princeton (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

NJ Bio, Inc. is seeking an ARD & QC Manager, Laboratory Operations to lead and manage diverse laboratory functions, ensuring efficiency and regulatory compliance in a cGMP environment. You will supervise QC teams and partner with management/vendors on equipment qualification.

Responsibilities include developing SOPs, conducting internal EHS self-inspections, managing inventory, coordinating outsourced testing, and driving CAPAs and OOS investigations while maintaining GDP documentation.

Qualifications

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• Minimum 3 years of QC laboratory experience.
• Experience with EHS and cGMP compliance.
• Willingness to work outside normal business hours as needed.

Responsibilities

• Perform work safely and in compliance with EHS 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 outsourced analytical and metrology testing.
• Develop SOPs and SOPs for calibration and OQ of equipment.
• Develop qualification/validation protocols for software.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Manage lab chemicals and consumables inventory.
• Lead internal self-inspections for safety and cGMP compliance.
• Prepare SOPs, protocols, and reports as needed.
• Conduct OOS risk assessment and root cause investigations; assist management.
• Write deviations, change controls, and CAPAs; assist management.
• Document work in lab notebooks/logbooks per GDP.

Skills

Microsoft Office

cGMP/ICH/USP/Ph.Eur

Analytical instruments

Communication

Interpersonal skills

Independent & collaborative work

Analytical thinking

Planning & time management

Availability for flexible hours

Education

BS/MS/PhD in chemistry/biology/biochemistry

BS with 6+ years experience

MS or higher with 4+ years experience

Job description

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 managementSupervise, train, and mentor junior QC scientists and associate scientistsDevelop and implement corrective and preventive actionsChemical and consumables inventory managementInternal safety and cGMP self-inspectionsSample management, including outsourced testingEHS managementThe 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 contractsManage and schedule work outsourced to third-party analytical and metrology service providers.Develop procedures and SOPs for calibration and OQ of equipmentDevelop protocols for qualification/validation of softwareMaintain, 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 compliancePrepare 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 OfficeKnowledge 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 DemandsTypically 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 environmentCompensation:$100,000-$130,000NJ 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