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:

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/innovative-medicine.

We are searching for the best talent, Supervisor , Manufacturing Assembly This position is based in Raritan New Jersey..

The Lenti Operations Supervisor is an exempt level position working within Lenti Operations team, responsible for directing the daily production of lentiviral vector to support our commercial BCMA CART product in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Major Responsibilities:
• This individual will lead and supervise the lentiviral vector end to end manufacturing process according to standard operating procedures, batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Will lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
• The primary responsibility will be to work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• They will support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls. Will work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• This individual will need to build strong partnerships with Manufacturing investigations, Facilities, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• This individual will support the optimization of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within Lentiviral vector manufacturing Operations.

Knowledge and Skills
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of drug substance products, and cleanroom behaviors.
• Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records
• A working leader who can participate in production runs in critical situations when needed.

Qualifications:
• Bachelor's degree in Science, Engineering or related field or equivalent experience required.
• A minimum of two (2) to four (4) years of operations experience within a cGMP environment in the biotech/biopharma industry is preferred.
• Prior experience in an aseptic manufacturing environment and leadership positions.
• Prior experience in manufacturing, quality, or engineering is required.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
• Experience working in cGMP systems including MES lite, eLIMs, Siemens, and SAP is preferred.
• Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required.
• This position may require up to 10% of domestic travel.

Required Skills:

Preferred Skills:
Agile Manufacturing, Assembly Operations, Coaching, Controls Compliance, Data Savvy, Developing Others, Efficiency Analysis, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Manufacturing Processes, Manufacturing Science and Technology (MSAT), Plant Operations, Predictive Analytics, Predictive Maintenance, Process Oriented, Technologically Savvy, Troubleshooting

The anticipated base pay range for this position is :
79,000-120,700

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