Manager/Technical Lead, Assay Development

Job Description
Job Description Lead an immunoassay development team and work with internal and external collaborators and cross-functional teams to execute immunoassay-based IVD product development plan and support the success of product development programs.


Major Accountabilities:

Serve as a Technical Lead and subject expert for immunoassay-based IVD diagnostic assay and product development including analytical QC methods development and validation for critical reagents.

Lead and manage immunoassay development team and work with internal and external multidisciplinary teams to execute technical strategies and project plans.

Manage day to-day operations in immunoassay lab including critical reagents development, technical transfer of critical reagents, development of analytical QC methods for critical reagents, develop risk assessment and backup strategies for critical reagents supply.

Assume technical leadership role, assess technical feasibility, develop and execute technical strategies, identify technical risks, develop and execute risk mitigation plan(s) to manage technical risks, drive technical discussions and decisions.

Draft, review, edit and complete study plans and technical documents required during critical reagents development, analytical QC methods validation, various stages of product development and for regulatory submissions

Work with cross-functional team to manage and coordinate internal and external assay/technology/reagent/product development activities and budgets, and ensure project timelines and milestones are met.

The candidate is accountable for effective utilization and implementations of critical assay/product development tools (such as DOE and DFSS).

The candidate is accountable for effective utilization and implementations of critical assay/product development tools (such as DOE and DFSS).

Key Performance Indicators
Develop technical plans with clearly defined aggressive and achievable objectives, as well as timelines, key milestones and resource requirements.

Ensure successful executions and completions of the technical/project plans within the defined timelines and budgets.

Establish functional excellence and core capability for immunoassay-based IVD assay, reagent, and technology platform development to support Novartis MDx IVD product development.

Recruit talent and build project team; manage and lead the team

Minimum requirements Education:

The candidate must possess a PhD in a relevant scientific field, such as biochemistry and immunology with at least 7+ years of industrial experience for immunoassay development.

Languages: English

Qualifications: In-depth knowledge of immunoassays and various immunoassay platforms including Point-of-Care technologies, and 7+ years of hands-on experience in immunoassay are required. Technical expertise in key disciplines of IVD product development is highly desirable.

3+ years of management and leadership experiences required. Strong management and leadership skills with proven ability to direct and lead functional (assay development) team(s) and to collaborate effectively with internal and external stake holders in a highly dynamic environment.


Excellent writing and verbal communication and presentation skills are essential.
Experience in drafting, reviewing and editing documents required for product development, regulatory submission and quality compliance is required.

Ability to perform under pressure and adapt to changes (e.g., priorities and timelines) are important.

Specific Professional Competencies: Proven technical expertise for immunoassay-based technologies is must

Proficient in management and leadership skills required

Expertise in Point-of-Care technologies is highly desirable

Proficient in IVD product development process critical

Company

Novartis Corporation

Job Code

State or Province

Massachusetts

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