Pharmaceutical Manufacturing Technician

The Fountain Group LLC

Rockville, MD

JOB DETAILS
SALARY
$25–$28 Per Hour
SKILLS
Asepsis, Bill of Materials (BOM), Biological Processes, Biology, Cell Cultures, Cleanroom, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Documentation, Drug Development, Drug Manufacturing, Experiment Design, Identify Issues, Manufacturing, Manufacturing Equipment, Manufacturing/Industrial Processes, Materials Management, Microsoft Excel, Microsoft Word, Operations Management, Process Analysis, Process Development, Process Improvement, Reconciliation, Safety/Work Safety, Staff Training, Standard Operating Procedures (SOP), Startup, Technical Writing, Time Management, Training/Teaching, Writing Skills
LOCATION
Rockville, MD
POSTED
1 day ago
Pay: $25 - $28/Hour

Duration: 12+ months

Schedule Options:
  • Sunday – Wednesday (7 AM – 5:30 PM)
  • Wednesday – Saturday (7 AM – 5:30 PM)
 
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.
 
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 AstraZeneca standards.
• Weekend work may be required.
 
Education & Experience Requirements:
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.
• 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
 
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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/