Werfen ยท 2 months ago
Director, Assay Development
US-GA-Norcross
Full-time
Onsite
Director/Executive
10+ years expWerfen is seeking a Director of Assay Development to lead strategic planning for assay and product development teams aligned with corporate objectives. This role involves overseeing the discovery, design, and optimization of diagnostic products and assays while ensuring compliance with regulatory standards.
Health CareHospitalManufacturingMedical Device
Responsibilities
Lead the assay and product development teams, providing scientific and technical guidance
Create a culture of design control principles focused on developing state of the art products with the highest degree of quality
Develop and execute strategic plans for assay and product development aligned with company goals
Collaborate with executive leadership to define product development roadmaps
Oversee the discovery, design, optimization, and feasibility of serological, molecular, immunohematology products and assays
Ensure robustness, reproducibility, and scalability of assays for clinical and commercial use
Evaluate and implement new technologies and platforms to enhance assay performance to meet clinical needs
Develop and execute project plans, ensuring adherence to timelines, budgetary constraints and regulatory requirements
Foster a culture of innovation within the assay development team
Establish and maintain robust design processes to ensure the reliability and accuracy of diagnostic assays
Collaborate with regulatory affairs to ensure compliance with relevant industry standards and regulations
Mentor and develop scientific staff on design of experiments and data analysis, fostering a culture of innovation and excellence
Focus on potential patent and publication opportunities for the team
Recruit and retain top talent in assay development and related disciplines
Performs other duties and responsibilities as assigned
Qualification
Required
Ph.D. or Master's degree in Biochemistry, Molecular Biology, Immunology, or related field
Minimum of 10 years of experience in assay and product development within the IVD or life sciences industry
Proven leadership experience managing scientific teams and complex projects
Deep understanding of assay technologies (e.g., ELISA, PCR, NGS, etc)
Strong knowledge of regulatory requirements for IVD products
Excellent communication, organizational, and problem-solving skills
Strong verbal and written communication skills specifically related to complex biological concepts and technical documentation
Effective collaborator across departments and with cross-functional teams
Demonstrates ability to prioritize and manage multiple workloads efficiently
Intermediate proficiency in Microsoft Office (Word, Excel) and specialized systems (TrackWise, MasterControl, SharePoint)
Receptive to feedback and direction; works cooperatively with managers and peers
Proven ability to work independently and as part of a team
Organized and detail-oriented with strong problem-solving skills
Committed to continuous improvement and operational excellence
Maintain records and files of work and revisions according to procedures and processes by following cGDP
Company
Werfen
Werfen is a developer, manufacturer and distributer of IVD testing solutions.
5001-10000 employees
H1B Sponsorship
Werfen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Dominique Petitgenet
Chief Operating Officer, Transfusion & Transplant
Ken Vogel, HCS
Human Resources Business Partner
Recent News
MarketScreener
2025-12-17
2025-12-08
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