Scientist Cell Manufacturing

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 working with our Cell Manufacturing team in a fast-paced, team and results-oriented work environment. We are looking for a talented scientist with flow cytometry experience to support the manufacturing line with assay development and validation, team training, and Quality initiatives.

The CM Scientist will perform analytical method development for cell culture-based processes and will collaborate on projects related to optimizing processes for bioengineered organs. The candidate’s primary responsibilities will include supporting and participating in experimental design, executing the planned experiments, and optimizing the process steps to the target process scale.

The candidate will participate in development studies to identify and determine appropriate ranges of (critical) process parameters for cell culture, to optimize growth and product manufacturing. The position will be required to coordinate method troubleshooting and investigations. Test Method, Qualification Protocols, and SOP oversight will also be required, using knowledge of cGMP/cGTP practices to incorporate the appropriate regulatory requirements into the methods and procedures.

The candidate will record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and also draft technical documents and perform technology transfer for GMP manufacturing from the research and development collaboration partners.

The position will largely independently oversee a wide variety of complex tasks that support the establishment, process control, and release methods for Cell manufacturing. The candidate is expected to work in a team environment as well as contributing individually to meet project timeline and objectives.

• Builds in depth process understanding by evaluating the effects of cell culture medium components and bioreactor process parameters on process performance, product quality attributes, and cell metabolism.

• Develop and optimize analytical methods to support establishment and control of process parameters; methods include Flow cytometry, biomarker identification, and functional assays.

• Design and execute experiments related to Analytical method development, sample preparation, data collection, analysis, and presentation

• Create study protocols, ensure effective, high-quality, timely and appropriate documentation of study conduct, for generation of study reports and internal Scientific Reports.

• Design and execute development studies to identify and determine appropriate ranges of (critical) process parameters for cell culture, to optimize growth and high-quality product generation.

• Lead the tech transfer of robust, efficient, and scalable cell culture processes to GMP production area to manufacture products that can be used to support clinical studies.

• Adherent culture of human cell lines

• Assay and process development and validation

• Develop, review, and follow standard operating procedures

• Lead process deviation and contamination event investigations

• Data collection, analysis, and presentation

• Develop, implement, and adhere to Quality initiatives and standards

• Ensure compliance with documentation and Batch Record standards

• Maintain proper environmental controls and monitoring within the manufacturing facility

• Back up operator on the Cell Manufacturing line

• 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

• Working knowledge of analytical testing requirements, methodology and equipment such as Cell Culture, Cell Counters, Plate Readers, Flow Cytometry.

• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products.

• Broad experience in the biopharmaceutical industry with a strong understanding of clinical development, including phase appropriate quality requirements.

• BS degree in one of the Life Sciences or Engineering disciplines including Biomedical Engineering, Cell Biology, or Tissue Engineering

• Highly proficient in flow cytometry, including preparation, data collection, and data analysis

• Strong mammalian cell culture expertise plus knowledge pertaining to other heterologous expression systems.

• Experience in adherent mammalian cell culture with at least 2 years of experience with confidence and proficiency in aseptic technique

• Demonstrated proficiency in design of experiments and data trending analysis.

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

• Ability to deal with ambiguity enabling creative and pragmatic approach to problem solving.

• Excellent organizational, verbal, written, and interpersonal skills are essential

• Enthusiasm for a collaborative work culture and desire to make a positive impact

Preference will be given to applicants with prior cGMP cell culture experience and previous work in controlled environments. Applicants with documented proficiency in flow cytometry are highly encouraged to apply.

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.