Job description
Overview:
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Job Summary
This position will develop, implement and manage activities related to research use only (RUO) and analyte specific reagents (ASR) at Werfen Autoimmunity to support the company’s strategic plans for product and business development. Responsible for expanding the company’s RUO/ASR program to generate demand for novel biomarkers, particularly related to those with early stage biomarker intellectual property (IP). This position will work closely with Autoimmunity’s Senior Leadership, as well as many functional areas of the company. Responsibly for ensuring all activties are carried out in accordance with established procedures, policies, and all applicable Standard Operating Procedures SOPs), FDA, and ISO regulations.
Responsibilities:
Skills & Capabilities:
Travel requirements:
30%, with potential for some international travel.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Job Summary
This position will develop, implement and manage activities related to research use only (RUO) and analyte specific reagents (ASR) at Werfen Autoimmunity to support the company’s strategic plans for product and business development. Responsible for expanding the company’s RUO/ASR program to generate demand for novel biomarkers, particularly related to those with early stage biomarker intellectual property (IP). This position will work closely with Autoimmunity’s Senior Leadership, as well as many functional areas of the company. Responsibly for ensuring all activties are carried out in accordance with established procedures, policies, and all applicable Standard Operating Procedures SOPs), FDA, and ISO regulations.
Responsibilities:
Key Accountabilities
Develops and manages Werfen Autoimmunity’s RUO and ASR activities.- Develops and meets budget goals for related activities.
- Collaborates with other Autoimmunity functional areas and departments, including the Autoimmunity SBU team (Marketing, Global Support), Quality & Regulatory, Finance, etc.
- Monitors the domestic and international environment and collaborates with Autoimmunity Marketing to identify new global RUO/ASR opportunities.
- Facilitates Research and Devleopment (R&D) activties related to RUO/ASR activities.
- Supports the creation of RUP/ASR processes, with an emphasis on customer facing activities and priorities.
- Serves as primary contact to manage relationships with RUO/ASR partners, with a special focus on key accounts in the US.
- Interacts with customer support for RUO/ASR related products.
- Complies with all applicable standard operating procedures (SOPs), QSR regulations, as well as Environmental Health & Safety (EH&S) Human Resources and other regulatory and administrative policies.
- Reflects company values in the quality of work and in working relationships
- Provides support for customer calls requiring R&D interactions. Collaborates with Commercial and Global Marketing, Quality and Regulatory and Technical Support teams to maximize customer experience and efficient use of R&D resources.
Reasonable accommodations may be made to enable individuals with disabilities to per-form these essential functions.
Networking/Key relationships
- Research and Development teams
- Marketing & Global Support teams
- Quality & Regulatory
- Finance
Minimum Knowledge & Experience:
Master’s degree in biological or related science required, Ph.D preferred.
Experience:
- 8+ years experience in product development, research, or related functional area in a regulated medical device environment required, preferably in IVD or autoimmunity.
- Experience with RUO and ASR activities required, preferably in a leadership position.
Skills & Capabilities:
- Keen understanding of the autoimmunity diagnostic industry.
- Exceptional ability to analyze the autoimmunity industry and develop strategies to leverage new product development opportunities.
- Strong expertise in domestic and international regulations related to RUO and ASR activities.
- Proven track record of developing and maintaining organizational partnership relationships.
- Deep understanding of the research and development process including design controls, quality system regulations, and regulatory requirements for the design, development and commercialization of of diagnostic technologies and products.
Travel requirements:
30%, with potential for some international travel.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
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