General Summary
The R&D team is looking for a senior engineer to be a part of a multidisciplinary R&D team revolutionizing regenerative medicine by developing new products and assays. The engineer will be expected to play a pivotal role in the design and development of novel cell- and tissue-based products, therapeutics and concomitant assays. This role will involve generation of prototypes alongside the development and characterization of new capabilities. This person will work closely with R&D scientists to provide proof-of-concept data and aid in the transfer of prototypes from feasibility into full development.

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Major Duties and Responsibilities

Essential Tasks

• Train and supervise junior staff and implement all relevant facility policies and procedures. • Competently perform all assigned departmental duties. • Test platform design, system integration and verification pertaining to miniaturization. • Design and fabricate microfluidics platforms to miniaturize assays to characterize stem cells and test for potency. • Use photolithography, thin film deposition, soft-lithography and/or other technologies to successfully develop a range of miniaturized platforms to aid in assay development. • Programming using COMSOL, LabView, and MatLab for instrument control and simulations. • Mechanical component design using CAD and Fusion 360 to further R&D efforts in 3D prototyping, printing- polymers, gels and cells. • Statistical data analysis using MiniTab, Spotfire, and/or GraphPad. • Factorial design of experiments for multivariate experiments and data analyses. • Generation and maintenance a stable human-derived stem cell line. • Expansion and differentiation of xeno-free human-derived stem cells. • Develop and conduct lineage-specific functional assays for stem cells and extra cellular vesicles. • Expansion, differentiation and cryopreservation of stem cells. • Isolation, processing and characterization of extracellular vesicles and cryopreservation. • Conduct testing for the presence of endotoxin and mycoplasma species. • Develop and conduct cell viability, migration and chemotaxis assays. • Evaluate laboratory processes and continue to identify and validate process improvements. • Responsible for authoring all relevant technical reports detailing process and analytical methods transfer, production and testing of development batches, preclinical safety/toxicology batches and GMP grade clinical batches. • Support QA and the Quality Management System by assisting in employee training, raw material and product management, document control, validation support, calibration and preventative maintenance support, deviation reporting, CAPA, risk analysis, etc. • Keep abreast of trends in the field by reading professional journals and attending relevant meetings and seminars. Use independent judgment and/or knowledge to resolve highly complex problems. • Develop new technologies or assays and participate in research activities. • Evaluate experiment results in an accurate and timely manner and recognize and report unusual test results. • Prepare and maintain reports/records and perform computer data entry. • Maintain departmental supplies within established inventory levels. • Commit to and embrace the mission, vision, and core values of BioBridge Laboratories. Maintains a positive and collaborative work attitude. • Demonstrate: Respect for co-workers and management staff Excellent customer service [for both internal and external customers] Adherence to all safety, regulatory, and quality requirements Continuous improvement • Participate in team oriented work projects for the development and implementation of strategic initiatives, validations, process improvements, and Standard Operating Procedures (SOPs).

Performs other duties as assigned.