Immunoassay Development Manager: Becton Dickinson & Company (BD)
| Job ID | PRO100O6 |
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| Company Name | Becton Dickinson & Company (BD) |
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| Job Category | Science/Research; Healthcare |
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| Location | Durham, NC |
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| Position Type | Full-Time, Employee |
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| Experience | 10-15 Years Experience |
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| Desired Education Level | Other |
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| Date Posted | July 8, 2009 (Reposted Dec 18) |
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| View Becton Dickinson & Company (BD) profile and job listings |
This position will manage the development of IVD tests for detection of cancers, including development of procedures, reagents, calibrators and controls. This position will also manage the successful integration of assays with instrument test systems for a multiplex immunoassay platform. This position will manage the design, development, verification and validation of in vitro diagnostic products in an FDA-regulated and design-controlled environment. Principal Accountabilities: - Responsible for designing and developing immunoassays for oncology diagnostics.
- Responsible for managing the immunoassay development scientific team.
- Responsible for the development, execution and documentation of test protocols and reports.
- Deliver new products on schedule and within specifications.
- Oversees the development of new products that result in increasing ratio of new product revenue.
- Interact and communicate effectively in team environment. Participate as the R&D representative in multi-functional project teams.
- Conducts periodic organizational assessments and facilitates the Human Resource Planning process within the R&D organization to assess strengths/skill sets and develop plans to address areas requiring strengthening.
- Exercises responsibility for associates' training, development, and motivating supervised associates.
- Monitor new technology and technological breakthroughs as a means of maintaining competitive advantage. Understands and leverages published research in experimental area.
- Participates in development of external business collaborations and alliances, taking a leadership role in those that are related to business strategy and immunoassay development.
- Support design control practices and good laboratory practices for new diagnostic product development through laboratory documentation, preparation and adherence to standard operating procedures, and presentation of laboratory results.
- Responsible for the publishing, patenting and presenting scientific findings.
- Responsible for supporting the identification and selection of suitable system technologies, including identification of suitable vendors and recommendations for capital equipment purchases.
- Responsible for timely completion of system test protocols, reports and other documents to support system development.
- Manage development alliances, joint ventures and/or collaborations with business partners and academic organizations.
Job Dimensions: - Working in a matrix, across organizational and business unit boundaries and within ambiguous environments
- Must operate with a sense of urgency.
- Leading cross-location and cross functional teams
- Ability to manage multiple priorities.
Education and Experience Required: - Masters degree in immunology, biochemistry, molecular biology or a related field.
- Minimum of 10 years experience in immunoassay development
- Proven experience in designing, developing and successful commercialization of multiple in vitro diagnostic (IVD) products
- Previous experience managing the development of immunoassay products
- Must have specific knowledge of immunoassay format and detection technologies
- Experience supporting FDA 510(k) and/or PMA submissions for IVD products
- Statistical based experimental design (DOE) experience and working knowledge of analytical software, such as Minitab
- Experience with assay integration on automated platforms, and verification and/or validation of in vitro diagnostics on automated platforms
- Knowledge of product development process for complex systems and technologies.
- Intermediate or advanced knowledge of Microsoft Word and Excel
- Must possess the computer skills necessary to utilize commercial software packages such as data analysis, spreadsheets and word processing.
- Excellent verbal and written communication skills
Education and Experience Preferred: - PhD in immunology, biochemistry, molecular biology or a related field
- 5 or more years experience with development and formulation of biological controls
- Knowledge of multiplex immunoassay technologies
- Experience related to oncology products
- Specific knowledge of analyzers, methodologies and technologies for immunoassays and oncology testing
- Working knowledge of Microsoft Office (PowerPoint, Access and Project)
Supervisory Responsibility: Will directly manage approximately 4-5 R&D scientists in the Durham facility.
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