Senior Quality Control Specialist

2 weeks ago


Manchester, New Hampshire, United States Advanced Regenerative Manufacturing Institute Inc Full time
Position Overview

The Advanced Regenerative Manufacturing Institute (ARMI) is a prominent non-profit organization dedicated to enhancing the bioeconomy of the United States. As part of its innovative initiatives, ARMI is leveraging cutting-edge automation and analytical methodologies to create scalable, consistent, and cost-efficient manufacturing processes for cells, tissues, and organs.

The Senior/Principal Quality Control Associate will play a crucial role in collaborating with various teams to design studies and conduct experiments aimed at refining manufacturing processes for biological products. This position emphasizes a strong commitment to cross-functional collaboration, ensuring responsiveness to the diverse needs of ARMI's ecosystem, including partnerships with engineering teams and the Deep Tissue Characterization Center.

Key Responsibilities:

  • Engage in team-oriented process development to establish a quality control laboratory that meets phase-appropriate standards, including conducting process gap analyses and optimization.
  • Oversee the organization, planning, and execution of experimental designs in collaboration with scientists to enhance quality control testing for flexible cell-based products.
  • Assist in the creation and documentation of standard operating procedures and quality control methodologies.
  • Collaborate with management and quality assurance to implement appropriate GMP processes within the laboratory.
  • Participate in cross-training on various laboratory techniques to meet testing requirements.
  • Utilize microbiological expertise to develop and execute microbiological testing methods.
  • Summarize findings and present data during team meetings.
  • Work collaboratively to achieve ARMI's strategic and technical goals.
  • Maintain thorough and accurate documentation of laboratory activities.
  • Contribute to the effective management of laboratory resources and equipment.

Qualifications:

  • M.S. or B.S. degree with a minimum of 4 years of relevant experience in life sciences, particularly in microbiology, molecular biology, or biochemistry.
  • Exceptional organizational skills and meticulous attention to detail.
  • Proficient in executing complex culture protocols and managing multiple experiments simultaneously.
  • Strong verbal and written communication skills, capable of addressing both scientific and non-scientific audiences.
  • Excellent problem-solving and analytical abilities.
  • Self-motivated with a willingness to learn and adapt quickly.
  • Familiarity with microbiological techniques such as sterility testing, environmental monitoring, and growth promotion.
  • Experience with GMP or GLP practices and detailed reporting.
  • Background in quality control is preferred.
  • Experience in process development and/or design of experiments (DOE) is advantageous.
  • Knowledge of analytical techniques including real-time PCR, ELISA, flow cytometry, mechanical testing, histology, and immunostaining is preferred.
  • Experience in technology transfer is a plus.


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