Job Title: Manufacturing Specialist

Job Description

The Manufacturing Specialist plays a key role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment such as control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance.

Responsibilities

• Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and manufacturing standards.
• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.
• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, ensuring optimal performance and preventive maintenance.
• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards.
• Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance.
• Lead routine cycle counts and ensure accurate inventory tracking and control.
• Execute transactions within the ERP system, including material requisitions and production tracking.
• Ensure accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
• Lead investigations into deviations and Corrective and Preventive Action (CAPA) efforts, compiling data and information as required.
• Drive continuous process improvement, incident investigations, and deviation resolutions.
• Ensure all activities comply with safety policies, rules, and regulations, promoting a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Essential Skills

• Aseptic technique
• Cleanroom experience
• Sterile processing
• Cell culture
• GMP compliance
• Laboratory operations
• Decontamination
• Standard Operating Procedures (SOP)
• Medical device handling
• Environmental monitoring
• Troubleshooting
• Batch record management

Additional Skills & Qualifications

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.
• Experience: Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 2-3 years of proven expertise in a cGMP-regulated environment.
• Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.

Work Environment

You will be working in a lab and office setting. The lab is a cleanroom with level 10k and 100k cleanroom standards. You will be responsible for sterile gowning and must be able to stay certified for sterile gowning.

Pay and Benefits

The pay range for this position is $70000.00 - $70000.00/yr.

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 Winston Salem,NC.

Application Deadline

This position is anticipated to close on Feb 7, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $70,000