The Senior Custom Applications Scientist is responsible for:
- Advanced design and development of assays including flow cytometry assays for assessment of cellular response to changes in the normal physiological make-up. Theses assays could be used in clinical reference labs and also in evaluation of candidate therapeutics in development at Pharmaceutical and Biotechnology companies. Requires close interactions with team associates as well as other functional groups.
- Associate may specialize in a particular area of custom products offered, but has knowledge of all BD Biosciences custom products. Coordinates with other departments, to ensure that customer needs and expectations are met in an accurate and timely manner. Acquires new knowledge and skills to meet the changing demands of the department. Provides guidance and training when necessary. Exhibits general project management skills. As a skilledassociate, completes tasks in creative and effective ways. Understands implications of work and makes recommendations for solutions. Responsible for ensuring individual and department compliance with BD Biosciences quality policy. Contributes to the mission andfinancial objectives of the company. Works within a specificschedule and within a team environment to ensure customer satisfaction for BD Biosciences’ products and services.
Job Duties and Responsibilities:
- Responsible for interfacing with customers including active participation in discussions relating to the development of assays and products aimed at customer-specific applications. Trouble shooting in user-lab conditions and developing alternate strategies to an emerging problem.
- Performs and reviews experiments of other associates. Reviews, analyzes data and prepares it for final reporting following full quality documentation and procedures.
- Responsible for developing and writing controlled documents, SOPs, and maintaining high quality standards meeting ISO and GMP standards. Generation of production documents with specifications for GMP manufacture.
- Developing, formulating and executing Assay Validation and Instrument Validation protocols and procedures
- May make occasional field visits to customer sites to gain understanding of applications, customers’ requirements and assist field personnel with unusual problems.
- Promotes a safe work environment.
- Accountable for ensuring customer satisfaction by delivering quality end-product, while adhering to aggressive time lines and working with multiple functional groups like manufacturing, QA, Instrumentation etc.
- Provides technical guidance and training to other associates as needed. Monitors training needs within group and initiates new training as appropriate.
- Maintains on-going communications and works closely with R&D, Operations, Sales and Marketing with the goal of increasing the productivity. Monitors and evaluates new emerging technologies within and outside the company to improve products and processes.
- Follows BD Biosciences Environmental, Health and Safety (EH&S) policies and procedures.
- Takes responsibility for safety in immediate work area.
- Participates in EH&S programs.
- Notifies supervisors of all observed hazardous conditions or unsafe work practices.
- May provide recommendations on maintaining the safety of the work environment.
- Performs other related duties and assignments as required.
Knowledge and Skills:
- Minimum 5 years in assay and/or product development for clinical flow cytometry applications required
- Work experience in a clinical flow cytometry laboratory with expertise in running flow cytometers including validation protocols is required
- Thorough technical and operational knowledge of current generation of flow cytometers and associated software applications.
- Demonstrated ability to plan the development and production of multi component products including ability to work with various functional groups
- Proficiency in cell culture techniques, cellular assays, immunoassays is required.
- A demonstrated ability to develop quality assays and products for clinical reference lab leading to high customer satisfaction is required.
- Experience in data management, including analysis and uploading of data in various web portals.
- Familiarity with various quality systems such as GLP, GCP, GMP.
- Documentation skills with attention to detail in writing professional reports, SOPs and Validation documents is required.
- Experience in customer interactions and carrying out on-site technical demonstrations with emphasis on troubleshooting is highly desirable. Ability to properly document of such events is required
- Proficiency in Word, Excel, Power point, Visio and business management software is expected.
- Experience with PLIMS or other operational databases is desirable.
- Requires a highly motivated and energetic person with ability to shoulder responsibility and be able to maintain an enthusiastic team environment.
- A demonstrated ability maintaining current knowledge of recent scientific and technical developments in the field is expected.
Education and Experience:
- Typically requires a Ph.D. with a minimum 5+ years of related laboratory and technical experience in a production environment.
- Prior experience in a clinical flow cytometry laboratory is preferred.