Operations Supervisor

About the role

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Responsibilities

• Lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• 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.
• 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.
• Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
• Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• Build strong partnerships with Manufacturing, 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.
• Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.

Requirements

• Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
• A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Availability to work in a day shift (1st or 2nd shift) is required.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based 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.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• 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.
• Ability to lift a minimum of 25 lbs. and stand for a long period of time.

Qualifications

• Minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry.
• Bachelor’s degree in Science, Engineering or related field or equivalent experience.
• Excellent communication and organizational behaviors skills.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook).
• Availability to work in a day shift (1st or 2nd shift).
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• 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.
• Ability to lift a minimum of 25 lbs. and stand for a long period of time.

Skills

• Leadership skills
• Communication and organizational behaviors skills
• Proficiency with Microsoft Office tools
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors
• Strong analytical, problem solving and critical thinking skills
• Experience with Operational Excellence and/or Lean Manufacturing
• Ability to accommodate shift work including evenings and weekends as required by the process
• Ability to accommodate unplanned overtime on little to no prior notice
• 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
• Ability to lift a minimum of 25 lbs. and stand for a long period of time

Benefits

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Schedule

Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.

Location

Raritan, New Jersey, United States