Senior Research Engineer, Diagnostics
8 St. Mary's Street
Boston, MA 02215
WHAT WE ARE LOOKING FOR: Sorrento Therapeutics (“Sorrento”) is seeking an experienced Senior Research Engineer to join our team. WHAT YOU’LL DO: Lead technical design, development, and transfer to manufacturing efforts for health diagnostic assays to achieve business unit objectives. ESSENTIAL DUTIES AND RESPONSIBILITIES: Design and perform testing of sensor prototypes from concept through successful transfer to manufacturing including the development of new assay concepts, reagent characterization, testing prototypes, and transfer to scale-up. Work collaboratively with management, regulatory, quality, and manufacturing to define device design and development objectives. Engineer sensor devices to validate promising concepts for scale-up to the clinical trial phase of product development. Create Solidworks 3D models and 2D drawings, and create associated specifications throughout all stages of development from concept through commercialization. Ensure designs for the health sensor portfolio of products are informed by relevant product, user, and commercial needs and reflected in Target Device Product Profiles. Perform designed experiments (DOEs), document results of feasibility studies and engineering evaluations in lab notebooks and technical reports, and author Design Verification protocols and reports. Execute and comply with Design Controls and lead Design Reviews with strong cross-functional input and collaboration. Ensure device design and development documentation meets all domestic and international regulatory submission requirements Create and manage Design & Development Plans, Traceability Matrices, Risk Assessments (Design, Use, & Process FMEAs), Design Verification and Validation Testing, Design History Files, etc. Work closely with Manufacturing and Quality to design assembly fixtures, inspection fixtures, and equipment, and to develop manufacturing processes and test methods. Lead in the assessment, selection, and management of sensor-component and reagent suppliers required to accomplish design and development objectives. Assist in new IP filings and become familiar with the relevant IP landscape to help ensure a protectable Vix IP platform. Assist in authoring or co-authoring abstracts, publications, government funding proposals, as needed. Participate in key cross functional activities in support of sensor technology development including pre-clinical CRO activities, human clinical CRO activities, and protocol writing. Monitor the device competitive landscape and translate relevant threats and opportunities to the CTO and Platform Leader. EDUCATION AND QUALIFICATIONS: Doctor of Philosophy in Science degree in a relevant discipline (chemistry, materials science, chemical or mechanical engineering preferred) Highly motivated by being a leader-doer in a startup situation and an entrepreneurial environment. Minimum of 2 years experience in development and engineering of electrochemical devices including the assessment of novel electrodes and electrochemical sensing approaches. Demonstrated knowledge and success in engineering immunoassays for detection of a range of targets from small molecules to proteins. Experienced in use of Solidworks for engineering concept development and creation of design documentation. Demonstrated knowledge in materials science, electrochemistry, and biochemistry. Knowledgeable of medical device product development (CFR Part 25) and integration of device and clinical phases. Knowledge of Design-for-Manufacturing for combination products or medical devices. Experience in pre-clinical device testing with a CRO to support engineering design and device verification testing for a novel combination product (e.g. cadaver models, protocol design, IACUC). A team player who works effectively with other functions to problem solve in a way that meets both quality objectives and business goals. Exceptional written and verbal communication skills. Communicates proactively and effectively. Able to present to senior leadership audiences with concise/relevant summaries. Excellent organizational and project management skills. Detail-focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment. Have fun! Collaborate and learn with the team while developing innovative devices that result in therapeutic and life-changing benefits for patients. YOUR REWARD: Support scientists who are on the leading edge of immunotherapies for the treatment of cancer. Earn a competitive salary that allows you to focus your attention on your passion. A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, company paid holidays, and Flexible PTO, plus equity-based compensation. If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you! Principals only. Recruiters, please do not contact this job poster. Sorrento Therapeutics, Inc. is an Equal Opportunity Employer.
How to Apply
About Our Organization
ABOUT US Sorrento Therapeutics, Inc. is a clinical stage and commercial biopharmaceutical company focused on delivering innovative and clinically meaningful therapies to address unmet medical needs. Our vision is to leverage our proprietary G-MAB™ library in conjunction with proprietary targeted delivery modalities to generate the next generation of therapeutics for treating cancer, autoimmune, inflammatory, viral and neurodegenerative diseases. These modalities include proprietary chimeric antigen receptor T-cell therapy (CAR-T), dimeric antigen receptor T-cell therapy (DAR-T™), antibody drug conjugates (ADCs), oncolytic virus (Seprehvec™), lymphatic drug targeting (SOFUSA®), as well as bispecific antibody approaches. We are additionally developing pain management solutions, including our clinical candidates resiniferatoxin (RTX) and SEMDEXA™. In response to the global SARS-CoV-2 (“COVID-19”) pandemic, we are also developing and conducting clinical studies for potential coronavirus antiviral therapies and vaccines, including Abivertinib, COVI-MSC™, COVI-AMG™, COVIDROPS™, and COVI SHIELD™, and diagnostic test solutions, such as COVISTIX™ and COVITRACK™. We attract smart people who play well with others. We're small enough for your ideas to make a big impact, and large enough to offer you opportunities to grow professionally at any stage of your career. If you’re a quick learner, enjoy working in the biotech industry, and share our mission of providing ground-breaking impact to medicine, each other, and our patients, Sorrento Therapeutics is the place for you!