ROLES AND REPSONSIBILTIES
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Interface with functional leadership to understand system integration requirements and manage task priorities of group members to maximize impact relative to key business objectives.
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Establish operational objectives and high-level work plans on new and sustaining product development projects including determining resource demand and allocation to projects.
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Deliver new clinical research/RUO application to the market
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Work with team to develop new reagents applications for clinical research and RUO (Research Use Only) markets
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Identify and hire great talents to join the team. Identify development plans for team members. Offer coaching and mentoring and provide technical guidance where appropriate. Act as the advisor to associates to meet schedules and/or resolve technical problems.
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Formulate recommendations for policy and procedure changes that will improve overall engineering productivity as necessary. Identify and implement efficiencies for the group
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Collaborate with peers across functions to identify opportunities for process improvement and enhanced productivity for the team.
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Lead the team to achieve a Best-In-Class organization, demonstrated via benchmarking to comparable business across BD and industry.
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Serve as an internal expert for project milestone reviews, as well as informal reviews. Provide critical analysis of launch readiness of new products, with particular emphasis on anticipating challenges in early launch
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Manages and coordinates the resources responsible for the activities of the Systems verification and validation group that include: planning, timeline development, protocols writing, protocol execution and report writing.
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Create subject matter expertise within the team and establish necessary study designs/execution and data collection for marketing collateral.
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Determines scope of work for program tasks and establishes schedules.
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Maintains substantial knowledge of state-of-the-art principles and theories and contributes to scientific literature and conferences.
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Communicates program status, progress, problems, and procedures to upper management.
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Establish and harness scientific collaboration engagements with reputable local and international academic institutes
EDUCATION/QUALIFICATIONS
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Requires a Masters degree in Biology/Life sciences field
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Ph.D. in Biology/Life Sciences a strong plus
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Post-Doctoral in Biomedical sciences highly desirable.
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A minimum of five years' work and supervisory experience in the field required
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A minimum of five years’ experience in product verification and validation
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Previous experience in the biomedical industry is desirable.
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Previous experience with IVD instrumentation is desirable.
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Previous experience with FDA filing is desirable.
For more information please contact Tanya Cooke at 091 706706 or email your CV to tanya.cooke@collinsmcnicholas.ie
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