Job Title:

Cell Therapy Manufacturing Specialist Location:

Rockville, MD Duration:

12+ Months (Contract/Temp with the possibility of extension)

Shift:

1st Shift (Sunday

• Wednesday | 7:00 AM
• 5:30 PM (During the first 30-45 days, training schedule will be Monday-Friday, 8:00 AM
• 5:00 PM)

Pay Range:

$25/hr to $26/hr

Job Description:

We are seeking an Associate Specialist

• Cell Therapy Manufacturing to support clinical manufacturing operations in a state-of-the-art cell therapy facility.

This is an excellent opportunity for an early-career biotechnology or life sciences professional with cGMP manufacturing experience who is passionate about producing life-changing therapies. The successful candidate will support cell therapy manufacturing operations in a cGMP cleanroom environment, ensuring products are manufactured safely, accurately, and in compliance with regulatory requirements. This position requires strong aseptic technique, excellent documentation skills, and the ability to work collaboratively with cross-functional teams.

Key Responsibilities:

Execute manufacturing batch records, work instructions, and Standard Operating Procedures (SOPs). Prepare, operate, clean, and maintain automated cell processing, cell expansion, and filling equipment. Perform manufacturing activities within Grade A and Grade B cleanroom environments while following aseptic techniques. Complete GMP documentation accurately and ensure compliance with cGMP requirements. Author and maintain batch records, work instructions, and Bill of Materials (BOM). Assist with documentation reconciliation, deviations, non-conformance investigations, and Out-of-Specification (OOS) investigations. Review batch records, SOPs, and manufacturing documentation for accuracy and completeness. Support technology transfer and process development activities. Train team members on aseptic processing, equipment operation, GMP documentation, and manufacturing procedures. Troubleshoot manufacturing processes and equipment issues. Collaborate with Quality, Materials Management, Clinical Operations, and Process Development teams. Maintain a safe and compliant manufacturing environment. Support weekend work when required.

Required Qualifications:

Bachelor's or Master's degree in Life Sciences, Biology, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, or a related field. Bachelor's degree with 0-3 years of cGMP manufacturing experience or Master's degree with 0-2 years of experience. Experience working in a cGMP manufacturing environment. Hands-on experience with aseptic techniques. Experience with biologics manufacturing, cell culture, cell therapy, or viral vector manufacturing. Experience operating manufacturing equipment in sterile environments. Strong documentation skills with batch records and SOPs. Proficiency in Microsoft Word and Microsoft Excel. Excellent communication and interpersonal skills. Strong organizational skills and attention to detail. Ability to work independently and as part of a team.

Preferred Qualifications:

Cell therapy manufacturing experience. Viral vector manufacturing experience. Process development experience. Experience with automated cell processing equipment. Experience supporting technology transfer activities. Experience with deviations, CAPA, non-conformance, or OOS investigations. Knowledge of cleanroom operations and GMP compliance. (LH-R6) #IND2

Pay:

$25.00

• $26.

00 per hour

Benefits:

401(k) Dental insurance Health insurance Referral program Vision insurance Application Question(s): How many years of experience do you have working in a cGMP manufacturing environment? Do you have hands-on experience performing aseptic manufacturing or sterile processing in a cleanroom environment? Do you have experience operating manufacturing equipment used in biologics or cell therapy production? Are you comfortable working in a GMP cleanroom while following strict gowning, hygiene, and PPE requirements? This role requires working in a highly regulated manufacturing environment with strict cleanroom standards (including restrictions on jewelry, cosmetics, artificial nails, and similar items while in manufacturing areas). Are you able to comply with these requirements? Are you available to work the Sunday-Wednesday schedule (7:00 AM

• 5:30 PM), including the initial training schedule of Monday-Friday, 8:00 AM
• 5:00 PM?

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? Please confirm your email address and contact number. 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?

Work Location:

In person