Lenti Investigations, Senior Supervisor

Johnson & Johnson • Raritan, NJ

9h • Onsite

About The Position

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innov ative-medicine. We are searching for the best talent, . Lentiviral Vector Senior Supervisor, This position is based in Raritan New Jersey.. 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.

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

Nice To Haves

• A master’s degree is preferred.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior