GMP Technician, 2nd Shift Operations Support Team

Andelyn Biosciences, IncColumbus, OH
Onsite

About The Position

The GMP Operations Support Technician is responsible for supporting all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working in collaboration with the Manager of GMP Operations and staff, the Support Technician will provide hands-on assistance for all day-to-day GMP & Viral Vector Core production operations, including materials management, documentation, as well as facility and equipment maintenance and cleaning. A Support Technician will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate practices and Standard Operating Procedures (SOPs) for manufacturing biological products.

Requirements

  • Must possess a High School Diploma/Equivalent
  • No minimum experience
  • Must be computer literate in Microsoft Office (PowerPoint, Excel, Word)
  • Ability to work independently as well as collaboratively in a diverse and inclusive work environment
  • Must possess a client-focused mindset in daily tasks
  • Must possess prior experience handling confidential information and the ability to maintain confidentiality.

Nice To Haves

  • a background in the life sciences, biotechnology, or gene therapy industries preferred
  • Experience in highly regulated fields preferred
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

Responsibilities

  • Supports GMP resources and supply chain by ordering & maintaining materials inventory to meet production goals
  • Supports daily operational activities related to the GMP manufacturing of biological products by assuring the availability of materials with the proper documentation surrounding GMP activities.
  • Performs the cleaning and of facility equipment and systems as specified in SOPs and stocking consumables
  • Works in close collaboration with GMP Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
  • Works in collaboration with GMP Management and Staff to cultivate and enact the strategic direction of the GMP area as well as provide input on project timelines
  • Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate a high level of integrity
  • Maintain a positive attitude
  • Attention to detail in all job functions
  • Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
  • Performs tasks as assigned
  • Works under close supervision of senior staff and leadership
  • Functional working in a diverse and collaborative team environment utilizing clear communication to deliver high productivity
  • Documentation of all activities performed according to SOPs
  • Learning technical and professional skills
  • Other duties as assigned

Benefits

  • Competitive compensation
  • Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
  • 160 hours of Paid Time Off annually
  • 11 Company Paid Holidays plus 2 floating holidays annually.
  • Company Paid Life Insurance
  • 401(k) Match
  • Company Paid short and long-term disability.
  • 4 weeks of Paid Parental Leave for birth and adoption
  • Adoption Assistance
  • Tuition Reimbursement and Student Loan Repayment Assistance
  • Company Paid LinkedIn Learning access.
  • Employee Assistance Programs
  • Flexible work options (role specific)
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