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.
Non-Essential Tasks
Education
Required Minimum Education
Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment. Preferred Education
Prefer a Master's Degree from an accredited college or university. Licenses and/or Certifications
Experience
Required Minimum Experience
• Requires six or more years of tissue culture techniques experience. • If a Master's Degree is attained, requires four or more years of tissue culture experience. • If a PhD is attained, requires two or more years of tissue culture experience. • Requires proficiency in 3D printing and 3D-Bioprinting. • Requires experience in microfluidics design, fabrication and development. • Requires hands-on experience with Solidworks/Fusion 360 for prototype design, and COMSOL Multiphysics and MATLAB microfluidic device simulation. Preferred Experience
- Prefer programming experience in MatLab, Comsol, and LabView.Prefer experience in using Fluigent and ECIS platform.Prefer a background in cGMP principles and Quality Management Systems. Experience Exception to Education
In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge
Knowledge
• Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations. • Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc. • Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies. • Must have a working knowledge of tissue and cell culture. • Must have a specific understanding of two or more of the following subject matter areas: wound healing biology, bone biology, cell-based therapeutics and/or applied regenerative medicine. Skills
Skills
• Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions. • Must have excellent interpersonal and public speaking skills. • Must have excellent written and oral communication skills. • Must have strong computer skills. • Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies. • Must maintain competency in laboratory skills for liquid and material handling. • Must have basic library and literature-based research skills. Abilities
Abilities
• Must be able to commit to project delivery timelines and budget. • Must be able to keep information confidential. • Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently. • Must be able to work with interruptions, meet deadlines, and perform accurate laboratory testing. • Must be energetic, enthusiastic and have a team‐oriented leadership style. • Must maintain a good working rapport with co‐workers. • Must be neat in appearance and well groomed. Working Environment & Travel Requirements
Working Environment & Travel Requirements
Works in a well‐lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. May be required to work extended hours during peak periods. Occupational Exposure Assignment ‐ Category I Travel Requirements
Physical Requirements
Physical Requirements
Will sit, stand, walk, and bend during working hours. Requires ability to reach, lift and carry up to 50 lbs. Requires manual and finger dexterity and eye-hand coordination. Requires normal or corrected vision and hearing corrected to a normal range.
