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Technician Cell Manufacturing

Technician

Cell Manufacturing

Position Description:
Miromatrix’ mission is to eliminate the organ transplant waiting list by bioengineering transplantable organs to bring lifesaving technology to all those in need of a transplantable organ.
Miromatrix, Inc. is a biotechnology and regenerative medicine pioneer that discovers, develops, and delivers innovative, award winning biotherapies. We are currently developing transplantable bioengineered livers and kidneys as our lead products, with plans to expand into other organs as part of our business model. Our progress to date was recently recognized as a KidneyX prize winner for redesigning dialysis and as a 2019 Buzz of BIO for Pipelines of Promise. We continue to build our organization and manufacturing teams.
Miromatrix has an immediate opening for a highly motivated individual interested in joining our Cell Manufacturing team in a fast-paced and results-oriented work environment. We are looking for a talented technician to assist in the banking and expansion of cells according to cGMP standards to gain valuable industry experience in a manufacturing setting.
The incumbent will play a critical role for the culturing, plating, distribution, maintenance, and banking of cell culture lines. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and leading with minimal supervision. As a team member of the cell culture group, the incumbent will work to support cell and tissue culture activities.
Responsibilities:
• Primary operator on the cGMP Cell Manufacturing line, performing cell culture across a variety of cell lines, plate formats, and media conditions within specifications and timelines provided in the manufacturing batch records.
• Support creation and maintenance of working and active cell banks.
• Start up, scale up, and maintain multiple cell lines including large scale adherent culture of human cell lines
• Perform document change control activities to author, edit, and review controlled documents related to cell manufacturing, to ensure documents comply with applicable Miromatrix Quality System requirements
• Assist in process deviation and contamination event investigations in compliance with Miromatrix SOPs.
• Responsible for organizing data and preparing appropriate documentation, including presentation materials, investigations and for assigned projects.
• Implement and adhere to Quality initiatives and standards
• Maintain compliance with documentation and Batch Record standards
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to cell therapy, as well as technical understanding/problem solving capability.
• Must maintain adequate personal hygiene required for working in a cleanroom environment
• This position also includes wearing appropriate PPE (gowning for controlled environment) suit and surgical mask while navigating tight spaces
• Participate in regular site and Quality/Manufacturing meetings.
Required Qualifications:
• Laboratory skills and training including expertise in mammalian cell culture, aseptic technique, cell culture techniques, sterile media preparation, and clean room maintenance
• Experience in GMP manufacturing is a plus
• BS degree in one of the Life Sciences or Engineering disciplines including Biomedical Engineering, Cell Biology, or Tissue Engineering
• Highly proficient in adherent mammalian cell culture with at least 2 years of experience with confidence and proficiency in aseptic technique
• Excellent organizational, verbal, written, and interpersonal skills are essential
• Enthusiasm for a collaborative work culture and desire to make a positive impact
Desired Qualifications:
Preference will be given to applicants with prior cGMP cell culture experience and previous work in controlled environments.
Applicants must submit a resume and cover letter detailing why they are a fit for this position to wwoodley@miromatrix.com.
Miromatrix offers a competitive compensation package with great growth potential. The Company is committed to providing a safe, fair, and enjoyable work environment. Job offer will be contingent upon a pre-employment background check and drug screening. Miromatrix is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, and any other characteristic protected by law.