VP of Technical Operations and Manufacturing
Miromatrix Medical Inc. Eden Prairie, MN
- Posted: over a month ago
- Benefits: 401k, dental, medical, vision
Miromatrix, Inc. is a biotechnology and regenerative medicine pioneer with the mission to eliminate the organ transplant waiting list by providing bioengineering transplantable organs to all patients suffering from organ failure. Our culture is founded on the pillars of innovation, dedication, and integrity
We are currently developing a transplantable liver and kidney 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 scientific teams. Miromatrix has an immediate opening for a highly motivated individual interested in leading our Cell Manufacturing efforts in a fast-paced, team and results-oriented work environment. We are looking for an individual with a proven track record of success leading teams responsible for primary human cell isolation, scale-up of cell manufacturing, and/or implementation of cGMP in the medical device or biologics space.
The Vice President of Operations will provide leadership and guidance to an organization responsible for process development and optimization for a regenerative medicinal product using human tissue and cells. As the leader of all the developmental functions for biologics, this position represents a single point of CMC accountability for advancing Miromatrix’ regenerative medicine product pipeline. In addition, the VP will be a member of the CMC Team, which is responsible for preparation of regulatory dossier for submission to the FDA.
The VP of Operations will be tasked with designing and executing plans and protocols for, IND enabling studies and drafting the relevant section of the IND in collaboration with the Quality and Regulatory departments. The VP of Operation will also assist in the creating the necessary documents such as the briefing package, for pre-IND meetings and drafting the CMC section for the INDs.
In this role, the VP of Operations will provide guidance for analytical method development and validation, including characterization assays for pre-clinical and clinical stage programs ensuring that the analytical development activities are GxP compliant.
· Provide leadership and direction to the biologics process development organization, a department of ~15-20 staff that are engaged in various aspect of process development, material management, facilities management, and manufacturing operations
· Advance HCT/P expertise in pipeline by providing overall CMC oversight, direction, and decision.
· Provide strategic direction to manufacturing operations and process development projects through interactions with the Quality and Regulatory departments.
· Translating non-clinical and clinical study demand of an existing and new product candidate to development timelines and manufacturing strategy for IND and BLA readiness
· Develop and execute Process Performance Qualification (PPQ) studies in alignment with regulatory expectation in a phase appropriate manner
· Evaluate and implement new operational technologies to drive innovation in process development, optimization, testing, validation, and manufacturing
· Drive development and implementation of new systems to improve project execution and data management
· Establish robust, compliant, scalable GMP manufacturing processes that is phase appropriate, Guide manufacturing operations team in preparing manufacturing master batch record in collaboration with Quality department
· Oversee the writing of Standard Operating Procedures (SOPs) to support process development, cGMP and analytical testing needs
· Provide technical and strategic input and drives continuous improvement to the manufacturing process and analytical methods through technological innovation to support ongoing product development effort by conducting appropriate tests, experiments, and qualification studies to justify proposed changes
· Lead collaborations with Miromatrix cross functions such pre-clinical and clinical Research, Quality, Clinical Operations, and Regulatory Affairs
· Form and guide product development (CMC) teams consisting of representatives from each development function, to drive and manage each program that is under development
· Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections
· Provide technical support to internal and external (when needed) cGMP manufacturing operations
· Comply with all applicable laws and company policies regarding health, safety, and environment
· Developing department budget and managing department to that budget
Requirements and Qualifications:
· PhD in relevant Life Science or Engineering related disciplines
Preferable: 10+ years of biopharmaceutical industry experience with no less than 5 years of that experience focusing on biologics manufacturing process development utilizing mammalian cell lines
· Knowledge of laboratory and clean room operations and aseptic processing requirements
· Experience overseeing aseptic process and assuring the, material used are suitable and the facility and equipment and suitably maintained and fit for aseptic operations
· Thorough understanding and working experience with Quality by Design (QbD) and risk management principles
· Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process qualification leading to validation
· Experience defining process parameters, design space and control strategies
· In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics, including specification development, process and product impurity characterization and process optimization for purge and fate.
· Experience with HCT/P, donor eligibility requirements
· Experience with viral clearance studies
· Working knowledge and deep understanding of cellular processes and metabolism
· Experience supporting multiple regulatory filings including IND and BLA and supporting product-related inspections for US and foreign regulatory agencies
· In-depth technical and regulatory understanding of GMP biologics manufacturing, as well as applicable international regulations and standards in all phases of product development and commercialization
· Experience working with GMP contract service providers and testing organizations
· Experience with development and CMC of Cell and Tissue products, as well as working knowledge in molecular biology aspects and regenerative medicinal product.
· Exceptional interaction, leadership and command skills are required
Miromatrix Medical Inc.
Miromatrix is a Minnesota-based biotechnology company engaged in the development of fully biological human organs to solve the chronic shortage of transplantable organs utilizing its patented perfusion decellularization/recellularization technology, as well as the development of the next generation of acellular based products. This is a unique opportunity to join a growing company with novel products.
10399 W. 70th St Eden PrairieEden Prairie, MN
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