Sr. Manager/Manager, Research and Development Assay Feasibility

Overview

Job Summary

 

Autoimmunity Sr. Managers are responsible for the overall performance and business results of their assigned department(s). Responsible for department functional plans, determining current and future position profiles and staffing needs, proposing and managing department budgets, performance metrics and reporting, analyzing operations to identify gaps, ensuring compliance, safety, and ongoing process improvements, as well as leading and developing lower-level management staff, other direct reports, and high performing teams. Ensures business goals, deadlines and performance standards are met. Collaborates with department Senior Leadership, and other Autoimmunity functions to meet goals and produce the highest quality products and services. Ensures staff act in accordance with company policies, expectations, and values. All activities are performed in accordance with standard operating procedures, Quality System, safety, and administrative regulations.

 

Sr. Managers, Research & Development may oversee any of the following R&D departments:

 

Biomarker Discovery/Feasibility: Feasibility studies for the development of new products, and the improvement of existing products. Guides team in the evaluation of novel markers discovered in-house or through business development and literature research.

 

Assay Development: Verification and validation of new assays for commercialization. Includes execution of analytical and clinical studies to support registration and submission to regulatory bodies.

 

Manufacturing Technical Support: Technical support for manufacturing and other cr teams within the organization. Includes execution of analytical and clinical studies to support design changes if needed and registration and submission to regulatory bodies.

 

Clinical and Scientific Affairs: Collaboration with external organizations and key opinion leaders for study design and identification of new opportunities for the organization.

 

Project Management (PMO): Management of mid- and large-scale R&D Projects for new and enhanced Autoimmunity Products.Systems Test: Planning and execution of studies to ensure systems performance as designed.

Responsibilities

Key Accountabilities

 

Management Accountabilities

• Responsible for the overall performance of assigned department(s), including a well-trained and high performing, engaged workforce.
• Management and leadership to people managers and individual contributors within assigned span of control.
• Decides strategies and department goals to achieve company objectives. Ensures staff understand objectives and expectations related to them.
• Responsible for effective collaboration between assigned department and other departments and Werfen entities.
• Manages department headcount to ensure effective resource planning, including approval of all recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management.
• Develops, or provides input into, department budgets; monitors department expenditures.
• Determines the need for new or improved processes or resources. Delegates responsibility, or may directly author, implement, to ensure maintenance of departmental procedures, work in-structions, and templates associated with the department activities.
• Responsible for department metrics and data collection methodologies, including interpreting data to make recommendations to Department Senior Leadership. Prepares and presents re-ports and other presentations.
• Decides, leads, and influences department and cross-functional projects.
• Ensures effective use of company’s performance management program, including setting expectations, providing timely and meaningful feedback, ensuring understanding, holding staff accountable, while supporting employees’ development goals.
• Ensures regular and meaningful communication throughout the department, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication.
• Develops and delivers effective updates to executive management in formats appropriate for the topic and situation.
• Manages and leads lower-level management staff to ensure high performing teams and department operations. Includes accountability to Werfen’s People Manager Competencies and Expectations.
• Monitors department personnel and operations to pre-empt employee issues. Proactively manages employee relations issues; uses professional judgement in consulting with department senior l