Biopharma GMP Manufacturing Associate I

Bora Pharmaceuticals

Rockville (MD)

On-site

USD 60,000 - 62,000

Full time

9 days ago

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Benefits offered by this job

Competitive salary
Incentives
Health coverage
Retirement plan
Paid time off
Professional development
Wellness programs
Employee assistance

Job summary

Bora Pharmaceuticals is seeking a Manufacturing Associate I to support the production of biopharmaceutical drug products in a GMP environment. The role involves preparing materials, executing manufacturing steps, maintaining records, and coordinating with QA to ensure compliance with regulatory specifications.

The position emphasizes accuracy, safety, and teamwork within a fast-paced production setting, with the potential for professional development and involvement in multiple clinical programs.

Qualifications

  • High School Diploma or equivalent with exposure to science and math coursework and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
  • Associate's degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
  • Bachelor's degree in a related discipline with no experience

Responsibilities

  • Plan and communicate daily material needs and weigh materials for manufacturing
  • Prepare and test solutions; coordinate sample collection and submission
  • Maintain cleaning of the facility and equipment; assist with inventory and material transactions
  • Create and revise GMP documents including Master Batch Records, Work Instructions, and SOPs
  • Review cleaning logbooks for accuracy and ensure compliance with GMP
  • Collaborate with Quality Assurance to meet quality goals; maintain accurate records

Skills

Basic chemistry
Technical writing
Math calculations
Record keeping
Team collaboration
Quality focus
Problem solving
Equipment operation
Safety awareness

Education

High School Diploma or equivalent
Associate's degree
Bachelor's degree (related field) with no experience

Tools

Excel
Word
PowerPoint

Job description

Bora Pharmaceuticals is seeking a Manufacturing Associate I to support the production of biopharmaceutical drug products in a GMP environment. The role involves preparing materials, executing manufacturing steps, maintaining records, and coordinating with QA to ensure compliance with regulatory specifications.

The position emphasizes accuracy, safety, and teamwork within a fast-paced production setting, with the potential for professional development and involvement in multiple clinical programs.

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