Associate Specialist (Cell Therapy Manufacturing)

Job Description – Associate Specialist (Cell Therapy Manufacturing)

Job Title: Associate Specialist – Cell Therapy Manufacturing
Location: Rockville, MD 20850 (Onsite)
Duration: 12 Months (Possibility of Extension)
Work Schedule: Wednesday – Saturday | 7:00 AM – 5:30 PM

Job Summary

We are seeking an Associate Specialist – Cell Therapy Manufacturing to support clinical manufacturing operations within a cGMP-regulated cell therapy environment. This role involves manufacturing next-generation cell therapy products, maintaining GMP documentation, operating automated manufacturing equipment, and collaborating with cross-functional teams to ensure the successful production of clinical materials. The ideal candidate will have a strong scientific background, excellent communication skills, adaptability, and experience with aseptic manufacturing techniques.

Key Responsibilities

• Author, execute, and maintain manufacturing batch records, SOPs, work instructions, and bill of materials.
• Complete batch record reconciliation and ensure timely, accurate GMP documentation.
• Assist with deviations, non-conformance investigations, and out-of-specification (OOS) investigations.
• Operate, monitor, clean, and prepare automated cell processing, cell expansion, and filling equipment.
• Perform manufacturing activities within Grade A and Grade B cleanroom environments following aseptic techniques.
• Train manufacturing personnel on cGMP practices, aseptic processing, equipment operation, and documentation requirements.
• Review manufacturing documentation, logbooks, and SOPs for accuracy and completeness.
• Participate in technology transfer activities and process development initiatives.
• Support process improvements and optimization within the clinical manufacturing environment.
• Lead manufacturing floor activities, assign tasks, communicate product status during shift changes, and troubleshoot equipment or process issues.
• Maintain compliance with cGMP regulations and workplace safety standards.
• Collaborate with Process Development, Clinical Operations, Materials Management, and Quality teams.
• Support weekend operations as required.

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Engineering, or a related scientific field.
• Bachelor's degree with 0–3 years of cGMP manufacturing experience, or
• Master's degree with 0–2 years of cGMP manufacturing experience.
• Basic knowledge of biologics manufacturing processes, cell culture, or viral vector products.
• Experience with aseptic techniques and manufacturing in cleanroom environments.
• Familiarity with automated manufacturing equipment and/or process analytical technologies.
• Proficiency in Microsoft Word, Excel, and basic data analysis.

Preferred Qualifications

• Experience in cell therapy or viral vector manufacturing.
• Exposure to process development or technology transfer activities.
• Strong troubleshooting and problem-solving skills.
• Ability to work independently with minimal supervision.
• Adaptability in a fast-paced cGMP manufacturing environment.
• Excellent interpersonal and cross-functional communication skills.

Required Skills

• cGMP Manufacturing
• Aseptic Processing
• Cell Culture
• Biologics Manufacturing
• Cleanroom Operations
• Batch Record Documentation
• SOP Authoring
• Manufacturing Equipment Operation
• Microsoft Word & Excel
• Process Improvement
• Technical Documentation
• Cross-Functional Collaboration
• Problem Solving
• Communication Skills

Manager's Top Requirements

• Strong communication skills
• Adaptability and flexibility
• Hands-on aseptic technique and manufacturing floor experience

Work Environment

• Fully onsite position.
• Work in Grade A and Grade B cleanroom environments.
• Weekend work may be required.

Cleanroom & PPE Requirements

Candidates must comply with strict cleanroom and PPE guidelines, including:

• No jewelry (including smartwatches or fitness bands).
• No cosmetics except non-pigmented, non-scented moisturizer and lip balm.
• No nail polish, artificial nails, or eyelash extensions.
• No recent tattoos, piercings, or open wounds while working in the manufacturing environment.

Interview Process

• One panel interview with the Hiring Manager (virtual or onsite based on scheduling).

#IND2 JC - R6

Pay: $25.00 - $27.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Application Question(s):

• Are you a US Citizen or GCH? If on Visa please mention the Visa Status
• Are you ready for background check and drug screen in accordance with the local law and regulations?
• Cube Hub payroll is Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?
• What is your Expected Pay Range?
• Could you please confirm your email and contact Number?
• Do you have experience working in a cGMP manufacturing or cleanroom environment using aseptic techniques?
• Are you comfortable working onsite in Rockville, MD, Wednesday through Saturday from 7:00 AM to 5:30 PM?
• Are you able to comply with cleanroom PPE requirements, including restrictions on jewelry, cosmetics, artificial nails, and recent tattoos or piercings?

Education:

• Bachelor's (Required)

Work Location: In person

Salary : $25 - $27