R&D BIOLOGY MANAGER

Responsible for developing in vitro diagnostic assays to detect and quantify markers of infectious agents in clinical specimens. Particular focus on development of point-of care tests.
Products to be developed 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 product development.
Accountable for effective use of resources, timely execution of project schedules, meeting quality and Design Control requirements, and assuring that safe practices are observed in laboratory operations.
Scope of work may include laboratory and field research, product development, technical support and development of manufacturing processes.
Particular areas of interest are HIV & Hepatitis C.

Essential Duties and Responsibilities:
Manages up to 15 people
Responsible for leading multiple projects through Product Development
Responsible for fulfilling design control requirements for new products
Responsible for reviewing and monitoring reports
Collaborates with outside groups / companies
Responsible for multiple projects
Reduces scientific concepts to R&D feasibility
Develops and verifies specifications for new products and processes
Leads technology transfer and validation of new products & processes
Identifies and develops original scientific approaches
Evaluates new technologies for strategic fit
Presents to executive management on a regular basis
Identifies and generates research proposals and grants

Supervises and participates in the design, evaluation, and optimization of lateral flow or immunochromatographic assays using microparticulate labels. Assays will be based on competitive inhibition or 'sandwich' immunoassay concepts.

Supervises and participates in the preparation and qualification of reagents used in 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.

Supervisory Responsibilities:

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.

Qualifications:

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 lateral flow 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.

Education and Experience:

PhD in biological sciences with at least 7+ years in research and development in the in vitro diagnostic industry

Previous experience in leading technical teams responsible for the development of in vitro diagnostic assays including assays for infectious disease agents.

3+ years experience supervising 2 or more scientists and/or technicians engaged in diagnostic product development, including conducting performance evaluations and providing performance feedback.

Previous experience participating in cross-functional product development teams

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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