Job Title: Manufacturing Associate – Cell Therapy
Location: Rockville, MD 20850 (Fully Onsite)
Duration: 12 months (possibility to extend)
Shift: Four days a week, from Wednesday through Saturday, from 7:00 AM to 5:30 PM each day.

Description:
Job Title: Production Technician

Introduction: Associate Specialist (Cell Therapy Manufacturing) Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines?

Then this Client might be the place for you!

Main Duties & Responsibilities:

• Author and execute manufacturing batch records, work instructions and/or SOPs, with a focus ‘right the first time’.

• Author and maintain bill of materials.

• Assist with batch record reconciliation and timely documentation.

• Documentation of all activities to meet cGMP requirements.

• Assist with deviations/non-conformances/OOS investigations.

• Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grades A & B cleanroom environment.

• Train other personnel on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks.

• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as needed.

• Participate in tech transfer activities. Support process development of platform processes, contributing to the plans and designs of studies/experiments.

• May modify or improve processes and systems, depending on purpose of experiments

• Provides technical instruction to the team and allocates administrative work where possible –assigning tasks to other manufacturing staff, leading activities on manufacturing floor, communicating to staff about product status at shift change, troubleshooting processing and equipment issues.

• Ensures a safe work environment in accordance with client standards.

• Weekend work may be required.

Education & Experience Requirements:

• Education: Bachelor’s or Master’s degree in life sciences, engineering, or a related field

• Experience: Bachelor’s degree and 0-3 years of general cGMP manufacturing experience OR Master’s degree and 0-2 years of general cGMP manufacturing experience

Required Skills (Muts Have):

• Basic knowledge in biologics manufacturing process, cell culture and/or vector products.

• Technical proficiency in aseptic technique and working with manufacturing equipment in open and closed systems.

• Working knowledge of automated manufacturing equipment and/or process analytical technologies.

• Proficiency in Microsoft Word, Excel and data analysis.

Desired Skills (Not required, only preferred) :

• Previous manufacturing or process development experience with cell therapy or vector products.

• Dynamic individual with the ability to communicate and engage others.

• Independent and self-starting.

• Ability to work with minimal supervision.

• Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment.

(YR - R6)

#IND1

Pay: $25.00 - $27.00 per hour

Benefits:

• 401(k)

• Dental insurance

• Health insurance

• Referral program

• Vision insurance

Application Question(s):

• How many years of hands-on cGMP manufacturing experience do you have in a pharmaceutical, biotechnology, or cell therapy manufacturing environment?

• Do you have hands-on experience performing aseptic processing or working in a cleanroom (Grade A/B, ISO classified, or similar GMP environment)?

• Do you have a Bachelor's or Master's degree in Life Sciences, Biology, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, or a related scientific field?

• This position is 100% onsite in Rockville, MD and requires working Wednesday–Saturday from 7:00 AM–5:30 PM while following strict cleanroom PPE and grooming requirements. Are you able to meet these requirements?

• 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