Lenti Investigations, Senior Supervisor

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Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

The Senior Supervisor oversees day-to-day investigations activities for the LVV manufacturing process, ensuring GMP compliance, accuracy and timeliness of quality records. The Senior Supervisor carries out duties in compliance with all local, state and federal regulations and guidelines (including

FDA, EPA, and OSHA) as well as all company and site policies and procedures.

Key Responsibilities :

• Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.

• 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.

Key Proficiencies/Skills/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).

Education: Experience:

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.

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

94,000,144,500

Additional Description for Pay Transparency:

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off 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  Additional information can be found through the link below.  https://www.careers.jnj.com/employee-benefits