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GMP Manufacturing Associate

Iconma

Bothell, WA

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JOB DETAILS
SALARY
$31–$36 Per Hour
SKILLS
Biochemistry, Bioengineering, Cell Cultures, Change Management, Chemical Engineering, Communication Skills, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Drug Products, Equipment Maintenance/Repair, Fermentation, GMP (Good Manufacturing Practices), Health Plan, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Operations Management, Manufacturing Requirements, Manufacturing/Industrial Processes, Operational Support, Procedure Development, Procedure Implementation, Quality Management, Risk Analysis, Risk Management, Safety Compliance, Startup, Team Player, Time Management
LOCATION
Bothell, WA
POSTED
1 day ago
Our client, a Clinical-Stage Cell Therapy organization, is looking for a GMP Manufacturing Associate for their Bothell, WA location.
 
Responsibilities:
  • Supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies.
  • Work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations.
Startup Facility and Operations
  • Work collaboratively with the MSAT, Quality, Process Sciences and Vector Sciences on all aspects of facility qualification and start-up.
  • Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations. Execute the Day-to-Day Manufacturing Processing
  • Assist in development and implementation of GMP procedures and policies related to Manufacturing Operations.
  • Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
  • Maintain production facilities at a high standard of cleanliness and organization, perform equipment maintenance and calibrations as required, and complete and review GMP documentation in a timely manner.
  • Maintain appropriate level of training for assigned responsibilities.
  • Work with TechOps teams to execute technology transfers and capacity building projects.
  • Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.
Collaborate effectively:
  • Use strong communication and teamwork skills to build relationships across the manufacturing site.
  • Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
  • Support operational excellence initiatives, and the implementation of new technologies and systems.
  • Ensure a strong culture in safety and GMP compliance
 
Requirements:
  • 0 - 2 years of experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
  • Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
  • Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
  • Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
  • BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)
 
Why Should You Apply?  
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About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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