Responsible for the direction, planning, execution and continuous improvement of research and development activities for new product and technology planning, critical reagent development and validation and project management.
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.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
MINIMUM QUALIFICATIONS:
Formal Training/Education:
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).
Knowledge, Skills, and Abilities:
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
IVD Compliance
ISO 13485
Class I, II and III preferred
QSR
Delivery
Project management
Operations
KPI’s, scorecards etc
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