Lenti Investigations, Senior Supervisor

About the role

This position is based in Raritan, New Jersey.

Responsibilities

• Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
• Interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflict.
• Manage quality system metrics for deviations.
• Evaluate, track, and trend deviations.
• Accountable for reporting of deviation metrics at site and cross-site levels.
• Support internal and external audits.
• Guides daily work activities of 10-15 direct reports within the investigations organization under LV operations.
• Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
• Review/approve documents as an investigations department subject matter expert (SME).
• Support investigation of nonconformances, CAPAs and change controls.
• Set priorities and manage work assignments.
• Maintain individual and investigation team training completion in a compliant state.
• Communicate both within team and across departments.
• Foster a culture of compliance and strong environmental, health, and safety performance.
• Promote a mindset of continuous improvement, problem solving, and prevention.

Requirements

• Strong knowledge of Lentiviral vector/ cell/gene therapy processing.
• Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to Lenti operations and ability to identify/remediate gaps in processes or systems is required.
• Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for manufacturing.
• Ability to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Ability to accommodate unplanned overtime (including nights and weekends).

Qualifications

• A Bachelor’s degree with 4 years of deviation investigations experience and a minimum of two (2) years related supervisory experience is required.
• A master’s degree is preferred.

Skills

• Strong knowledge of Lentiviral vector/ cell/gene therapy processing.
• Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to Lenti operations and ability to identify/remediate gaps in processes or systems is required.
• Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for manufacturing.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

Pay

The anticipated base pay range for this position is: $94,000 - $144,500.

Schedule

Shifts include routine weekend and evening work as required by the manufacturing process. Ability to accommodate unplanned overtime (including nights and weekends).