Responsible for supporting development of in vitro diagnostic assays to detect and quantify markers of infectious agents in clinical specimens. Particular focus on Manufacturing Sciences and Technology (Factory Support) of legacy existing products for point-of care tests. Products include individual and multi-analyte tests performed in single use, disposable test devices. Responsible for organizing, planning, supervising and communicating the work of a team of scientists and technicians engaged in Factory support investigations, wet lab experimentation, product support, process improvement and technology evaluation. Accountable for effective use of resources, timely execution of project schedules, meeting quality and Design Control requirements, and assuring safe practices are observed in laboratory operations. Scope of work may include laboratory, Manufacturing line and field research, product development, technical support and development of manufacturing processes. Particular areas of interest are SAT, HIV, and Hepatitis C.
Manages up to 15 people
Responsible for leading multiple projects through investigations and to support Product Development
Responsible for fulfilling investigations under design control requirements.
Responsible for reviewing and monitoring reports
Collaborates with outside groups / companies as needed.
Responsible for multiple projects
Reduces scientific concepts to R&D feasibility
Develops and verifies specifications for new products and processes
Evaluates competitor or other products for strategic fit (OEM Acquisition etc)
Presents to executive management on a regular basis
May participate in core teams as required.
Supports Product Development as burst capacity periodically.
Supervises and participates in the design, evaluation, and optimization of experiments to determine root cause.
Supervises and participates in the preparation and qualification of reagents used in diagnostic assays. Eg. For lateral flow or other immunochromatographic assays. Will apply biochemical and biophysical techniques to develop measureable parameters to assure reproducibility and stability in product manufacturing.
Designs experiments, evaluates data, communicates results to others and determines subsequent course of action consistent with project and company goals. Trains technical staff in the design of experiments and proper use of controls.
Provides expert technical advice on competitor products, new products, and current scientific concepts that may lead to new products. Should maintain ongoing surveillance of marketing, scientific, and patent literature to stay abreast of new developments and products that may impact OraSure Technologies, Inc. business.
Prepares and presents papers at scientific meetings and/or publishes in scientific journals.
Writes invention disclosures describing patentable inventions arising from work performed.
Determines needs for clinical specimens for product development and participates in the planning of clinical and non-clinical studies.
Participates in or leads product development teams (core teams) operating under Design Control principles.
Assures compliance with all pertinent safety and regulatory policies.
Provides leadership and supervises the work of one or more scientists and technicians working together as a team on product development projects.
Prepares periodic performance evaluations of individuals supervised, develops performance objectives consistent with project and company goals, and provides regular feedback to improve performance and recognize superior performance.
Past experience in leading investigations to find root cause with use of investigative tools. In particular troubleshooting complex immunoassays such as competitive inhibition or sandwich immunoassay concepts.
Demonstrable experience in developing in vitro diagnostic products in the area of infectious disease
Demonstrable skill in developing clinical sample preparation methods that achieve product design goals.
Demonstrable technical skill and experience in the design and optimization of processes or other immunochromatographic assays that use microparticle labels is preferred.
Training in FDA Quality Systems regulations, including the practice of Design Control.
Demonstrable communication skills, written and oral, including a high level of proficiency with Microsoft Word, Excel, and PowerPoint software tools.
Demonstrable project management skills, including the ability to organize and plan realistic timelines for product development projects, meet project timelines, and communicate project information.
Knowledge of multi-factorial design of experiments software and its application to product optimization.
Willing to work at the bench to assist in teaching technical skills to subordinates.
Typically requires a Ph.D. with 15+ years of experience in running cGMP facilities under industrial setting.
Previous experience in leading technical teams responsible for the development of products or components of in vitro diagnostic assays including assays for infectious disease agents
8+ years experience supervising 6 or more scientists and/or technicians engaged in product development, including conducting performance evaluations and providing performance feedback.
Previous experience participating in cross-functional product development teams and investigations.
Previous experience in prototype immunoassay development, technology transfer, process and product validation, product claims generation and product labeling.
Expertise in optimization of formulations and production processes, conduct of Design of Experiments (DOEs) and evaluation of product performance
Previous experience in transferring prototype products into cGMP manufacturing, generation and verification of manufacturing processes and establishing product specifications
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