Car-T Operations Manager

Actalent • Allendale, NJ • 3h ago

Job Title: Operations Manager

Job Description

We are looking for an experienced Operations Manager who can efficiently and effectively make operational and manufacturing decisions that impact the quality of our products. The ideal candidate will analyze and seek opportunities to improve resource capacity and track personnel process proficiency. You will ensure compliance with GMP and applicable regulations, and ensure staff adherence to corporate and site-specific HR, safety, and business policies. Additionally, you will lead shift handovers, maintain accurate process records, and resolve technical, procedural, and equipment issues promptly.

Responsibilities

Make operational and manufacturing decisions impacting product quality.

Analyze opportunities to improve capacity availability and adherence to schedule metrics.

Ensure compliance with GMP, safety, and HR policies.

Alert and partner with EHS officers to resolve safety issues.

Lead shift handovers, assess schedule adherence, and provide status updates.

Maintain accurate process records including MBRs, work instructions, and logbooks.

Identify and resolve issues hindering production and compliance.

Assist in technology transfer to cGMP Manufacturing Operations.

Utilize Operational Excellence Principles to reduce process risks.

Perform cGMP and safety walk-throughs and assist with audits.

Coordinate with other departments for materials, testing, documentation, and scheduling.

Own and implement SOPs, BPRs, and other documentation.

Execute improvement projects and drive continuous improvement activities.

Design practices, processes, and procedures to meet customer expectations.

Partner with peer process owners to educate and communicate process performance.

Manage staff selection, training, evaluation, and development.

Support and report out metrics for Business Process Management and Strategic Enterprise Evolution.

Essential Skills

5+ years of experience in a cGMP environment.

Experience in aseptic processing, mammalian cell culture, and cryopreservation.

5-7 years of leadership experience.

Proficiency in pharmaceutical and GMP standards.

Experience with deviations, technical writing, and aseptic techniques.

Ability to oversee cGMP operations and supervise manufacturing staff.

Additional Skills & Qualifications

Bachelor's degree.

Experience in sterilization and aseptic production.

Ability to manage a large team or shift.

Work Environment

Work in an ISO clean room, managing 10-15 CGTAs. Initial shift is Sunday to Wednesday, 7am-5:30pm for the first 6-9 months. Afterward, the shift changes to Sunday to Wednesday night shift, 3:30pm-2am.

Pay and Benefits

The pay range for this position is $62.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Allendale,NJ.

Application Deadline

This position is anticipated to close on Sep 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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