Job Title: Manager - Aseptic Operations
Schedule: Sunday to Wednesday - 2nd shift
Position Summary
The Associate Manager, Manufacturing oversees cGMP operations, supervises manufacturing staff, and participates in hands-on activities as needed. This role ensures production remains compliant through active floor presence and leadership.
Essential Functions & Responsibilities
Make informed operational decisions that directly impact product quality, regulatory compliance, and manufacturing efficiency, using real-time data and floor observations.
Monitor resource utilization and production schedules to identify bottlenecks and implement strategies that improve throughput and adherence to timelines.
Supervise and mentor manufacturing staff, ensuring alignment with corporate HR policies, safety standards, and GMP regulations while fostering a culture of accountability and growth.
Lead structured shift handovers to communicate priorities, assess progress against production goals, and ensure continuity of operations through accurate documentation and team updates.
Troubleshoot and resolve technical, procedural, and equipment-related issues by collaborating with cross-functional teams and escalating when necessary to maintain compliance and productivity.
Coordinate with departments such as Quality, Supply Chain, Validation, and Maintenance to ensure timely availability of raw materials, testing, and equipment readiness.
Champion continuous improvement initiatives by applying Operational Excellence principles to streamline workflows, reduce risk, and enhance departmental performance.
Competencies
Proficient in Microsoft Excel, Project, and Visio for data analysis, project tracking, and process mapping to support operational planning and reporting.
Demonstrates strong interpersonal and communication skills to effectively collaborate across departments and influence outcomes in a matrixed environment.
Applies analytical thinking and structured problem-solving to identify root causes and implement sustainable solutions in a regulated manufacturing setting.
Capable of managing multiple priorities simultaneously in a fast-paced, evolving environment while maintaining focus on quality and compliance.
Maintains a proactive approach to regulatory compliance and fosters a culture of continuous improvement through training and process optimization.
Skilled in facilitating team meetings and managing group dynamics to drive alignment, accountability, and shared ownership of goals.
Upholds high standards of integrity and accountability, ensuring decisions and actions reflect company values and regulatory expectations.
Supervisory Responsibility
Directly supervises Manufacturing Associates I, II, III, and Leads, providing day-to-day guidance, performance feedback, and career development support.
Leads recruitment, onboarding, and training efforts to build a skilled and compliant manufacturing team.
Conducts performance evaluations, sets goals, and manages disciplinary actions in accordance with company policies and applicable labor laws.
Ensures team adherence to safety protocols, HR policies, and GMP standards through regular coaching and compliance monitoring.
Resolves employee concerns and operational challenges by fostering open communication and partnering with HR and EHS as needed.
Promotes a positive team culture focused on collaboration, accountability, and continuous learning.
Aligns team objectives with broader organizational goals to support strategic initiatives and operational excellence.
Qualifications
Bachelor's degree in a relevant field or equivalent experience.
2-5 years in cGMP manufacturing, aseptic processing, or cell therapy.
2-3 years of leadership experience or equivalent.
Experience with mammalian cell culture and cryopreservation preferred.
Quality Requirements
Embed quality into all work processes and maintain regulatory compliance.
Adhere to FDA and global quality standards.
Complete all required quality and compliance training on schedule.
Working Environment
Team-oriented, client-facing manufacturing setting.
Weekend, holiday, and flexible shift availability required.
Exposure to biological materials and chemicals; PPE required.
Operates in both office and cleanroom environments with standard equipment.
Physical Requirements
Must wear lab coats, gloves, and protective gear as needed.
Capable of physical tasks including sitting, standing, reaching, and lifting.
Proficient in using computers and office equipment.
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 10, 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.
