Manufacturing Associate

eTeam Inc.

Rockville, MD

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JOB DETAILS

SKILLS

Asepsis, Bill of Materials (BOM), Biological Processes, Biology, Cell Cultures, Cleanroom, Clinical Trial, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Drug Development, Experiment Design, Identify Issues, Manufacturing, Manufacturing Equipment, Manufacturing/Industrial Processes, Materials Management, Microsoft Excel, Microsoft Word, Operations Management, Process Analysis, Process Development, Process Improvement, Product/Service Launch, Safety/Work Safety, Staff Training, Standard Operating Procedures (SOP), Startup, Technical Writing, Training/Teaching, Writing Skills

LOCATION

Rockville, MD

POSTED

3 days ago

JOB TITLE: Production technician -Associate Specialist (Cell Therapy Manufacturing)
Location: Rockville, MD,20850
Duration- 12 months (possibility to extend)
Working Hours/Schedule:
Fully Onsite Sunday – Wednesday 7:00am – 5:30pm (first 30-45 days 8:00 am – 5:00 pm) x4
Interview Length: 1 hour
Interview Location: Onsite
JOB DETAILS:
Join the Clinical Manufacturing Cell Therapy Unit and be a part of producing client's next- generation products as we launch our first wave of cell therapy clinical trials. This position will support the start-up and cGMP operation of the new cell therapy manufacturing facility. Collaboration is key, and you will work together frequently with Process Development, Clinical Operations, Materials Management, and Quality Teams.

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's 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 | Master’s degree and 0-2 years of general cGMP manufacturing experience

Required Skills:
• 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:
•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.

Manager Top Must Haves:
Good communication skills (will be working in different rooms and cross functionally so this is really important for success)
Adaptability
Aseptic technique/On the floor manufacturing experience

NOTE: In this role contractors must follow proper PPE guidelines outlined byClient's
Jewelry (including apple watches and fitness bands) are not allowed.
Cosmetics are not allowed except non-pigmented/non-scented basic moisturizer and lip balm.
Nail polish, artificial nails, eyelash extensions, etc are not allowed.
Contactors cannot have recent tattoo's or piercings or open wounds.

About the Company

eTeam Inc.

Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Other/Not Classified

FOUNDED

1998

WEBSITE