Job Description:
Tasks:
Additional Info:
The company innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. JobLeads ist ein Premium Karriere Service für Senior Level Professionals. Der Fokus unserer Dienstleistung liegt ausschließlich auf dem gehobenen Stellenmarkt. Wir unterstützen berufserfahrene Spezialisten, Führungskräfte, Geschäftsführer und Vorstände, wenn Sie den nächsten Karriereschritt gehen möchten. Wir bieten diskreten Zugang zu Headhuntern und vorselektierten Karriere-Optionen. Hierfür analysieren wir die Stellen von über 130.000 Unternehmen und Headhuntern und stellen Ihnen passende Spitzenpositionen tagesaktuell vor. Darüber hinaus profitieren Sie von unserem Netzwerk aus über 20.000 Headhuntern und Personalberatern. Auf Basis Ihrer Karrierewünsche stellen wir Ihnen diskret die passenden Kontakte vor. [Click Here to Access the Original Job Post]
Tasks:
- New Product Development – Conducts feasibility studies. Develops reagents within F8 design control process and oversees validations. Oversees research and development of new products, as well as the transfer of products to Operations. Directs studies for Marketing and FDA approval and ensures GMP, ISO and IVDD compliant documentation.
- New Product Planning – Interacts with Marketing and Product Development teams to set product specifications, timing, resources and provide technical expertise.
- Oversees the critical reagent development, validation and transfer to Operations.
- Project Management - Oversees Antibody Innovation commitments and workstreams within cross-functional teams engaged in the development, commercialization and on-market support of critical reagent applications and new product development.
- Contributes to and drive execution of tRED technology strategies, roadmaps and strategic capabilities. Addresses strategic and technical issues; prepares departmental budgets; monitors and manages department infrastructure, operations and spending.
- Directs departmental staff including: interviewing and hiring staff, providing performance feedback and reviews, counseling, coaching and developing, rewarding, completing progressive disciplinary and terminating.
- Monitors work to ensure quality, and continuously promote Quality First Time.
- Oversees implementation of continuous improvement, R&D Lean and best practices (standard work) to drive quality, speed, productivity and efficiency, in alignment with departmental strategy and objectives.
- Ph.D. in a Life Sciences Discipline or related Computational Biology/Bio-Engineering disciplines (Biochemistry/Immunology/Pathology/Molecular Biology etc).
- 15 years combined academic and industry with direct experience in an IVD company. Experienced working with Marketing, Quality Assurance and Operations. 10 years of management experience. Demonstrated record of accomplishments (e.g., publications in scientific journals, issued US patents).
- Strong background in protein chemistry, bioinformatics and bio-engineering, focused on IVD assay development, such as immunoassays, immunohistochemistry or in situ hybridization and nucleic acid detection.
- Knowledge of Cell Biology, Pathology or Cancer Biology.
- Experienced in IVD product development and FDA submissions.
- Excellent leadership and communication skills, creative problem solver especially in technical areas.
- Familiarity with the various regulatory requirements (GMP, ISO and IVDD).
- Must work well with cross functional teams.
- Leadership
- Team-building, servant leadership
- Planning & financial
- Executive presence, business acumen
- Growing organizations, people, change management
- Technical
- All aspects of Ab development, especially against denatured or tissue antigens
- Polyclonal, monoclonal, recombinant (rabbit Ab preferred)
- Production, scale-up and transfer
- Purification, characterization, quality control
- Identity, quantity, purity, activity, quality
- Trouble-shooting & technical investigations
- Immunogen design
- Protein engineering & expression technologies
Requeriments :
Skills :
Areas :
Additional Info:
The company innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. JobLeads ist ein Premium Karriere Service für Senior Level Professionals. Der Fokus unserer Dienstleistung liegt ausschließlich auf dem gehobenen Stellenmarkt. Wir unterstützen berufserfahrene Spezialisten, Führungskräfte, Geschäftsführer und Vorstände, wenn Sie den nächsten Karriereschritt gehen möchten. Wir bieten diskreten Zugang zu Headhuntern und vorselektierten Karriere-Optionen. Hierfür analysieren wir die Stellen von über 130.000 Unternehmen und Headhuntern und stellen Ihnen passende Spitzenpositionen tagesaktuell vor. Darüber hinaus profitieren Sie von unserem Netzwerk aus über 20.000 Headhuntern und Personalberatern. Auf Basis Ihrer Karrierewünsche stellen wir Ihnen diskret die passenden Kontakte vor. [Click Here to Access the Original Job Post]