Sr. 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 leadership and Human Resources.
• Ensure risks to the business and employees are identified and mitigated through effective con-trols.
• Promotes a culture that supports and ensures team/department compliance with applicable Autoimmunity SOPs, ISO, FDA and other Quality System Regulations, as well as Werfen’s Code of Ethics, Human Resources, Environmental, Health & Safety, and other regulatory and administrative laws and policies.
• Represents the AID management team and reflects Werfen Values as a role model to employees, suppliers, and customers.

Research & Development Accountabilities may include:

• Responsible for research & development operations to identify and develop best in class prod-ucts, for autoimmune diseases and related conditions, that meet quality requirements, custom-er demand and profitability goals. Includes all activities related to identification of new bio-markers and development of products within assigned area(s).
• Participates in successful collaboration with external organizations (KOLs, customers, etc.) and other Werfen entities.
• Manages technical issues, root cause corrective action analysis, customer complaint investigation support, design of experiments, new product technology transfer support, and supplier technical assistance.
• Manages the development of new products to ensure design transfer from Research & Development to manufacturing and quality control.
• For new equipment, oversees the specification, selection, vendor contacts, installation, documentation, validation and training.
• Participates in scientific meetings and exhibitions and reports on new trends in autoimmunity research fields.
• Facilitates the improvement of products by investigating formulation changes or manufacturing procedures to improve product quality and/or optimize manufacturing processes.
• Maintains knowledge of academic and commercial technology trends and competitive develop-ments as input into strategic plans; acts as a key scientific resource to other departments.
• Decides priorities and projects within the Project Management team, assigns projects thoughtfully to ensure success. Monitors progress, collaboration and expenditures to meet milestones and goals.
• Decides priorities and projects within the Systems Test team to ensure successful performance of Autoimmunity equipment and software.

Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Research & Development teams
• Quality, Regulatory and Product Complaints teams
• Marketing & Service teams
• Manufacturing teams
• Autoimmunity Senior Leadership
• Human Resources, Finance, Facilities, IT, EH&S

Qualifications

Minimum Knowledge & Experience required for the position:

Education:

• Bachelor’s degree in biology or other life sciences related field required. Masters degree preferred.

Experience:

• A minimum of 10 years of progressive management and leadership experience required, within a regulated medical device environment required, preferably in IVD or autoimmunity.
• Experience in different diagnostic platforms, such as ELISA, indirect immunofluorescence (IFA), and/or multi-analyte technologies preferred.
• Proven track record of taking medical device products from inception through development and successful commercialization.
• At least 8 years of experience managing and developing junior level management staff required.
• Proven track record of building and managing successful business operations and high performing teams required.
• Senior Project Manager: At least 5 years’ experience leading mid to large complex R&D related projects required. Project Management Certification (PMP) highly preferred.
• Systems Test Sr. Manager: Minimum of five years’ experience successfully planning and executing medical device systems test operations required.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Deep understanding of design controls, quality system regulations and relevant regulatory requirements for the design, development and commercialization of diagnostic technologies and products.
• Strong understanding of life sciences related compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, or other regulations and standards).
• Ability to analyze and interpret scientific data, technical journals, financial reports, and government regulations required.
• Ability to decide operational plans to successfully achieve department and company goals.
• Understanding of business and employment laws and experience monitoring for compliance and prevention of employee relations issues and business risks.
• Advanced ability to constructively prevent and resolve conflicts.
• Critical thinking capability and decision making.
• Strong ability to function effectively with ambiguity in a rapidly changing environment.
• Strong influencing and negotiation skills, while building collaborative relationships and maintaining strong, positive working relationships.

Travel requirements:Limited travel requirements; less than 5% of time.

Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate.  This position is very active and requires varying levels of mobility. 

The salary range for this position is currently $135,000- $195,000. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com