Assay Development Manager/SubChapter Lead

Roche•Tucson, AZ

1d•$116,500 - $216,300

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As an Assay Development Manager/SubChapter Lead, you will be responsible for driving the technical and product development of IHC (Immunohistochemistry) assays. The role involves overseeing all aspects of assay development, including the evaluation, procurement, and management of physical, financial, and human resources necessary for the development of IHC reagent systems and associated instrumentation. As the leader of the IHC assay development team, you will ensure cross-functional technical alignment throughout the product life cycle and facilitate collaboration across various company functions to accelerate product development and commercialization. You will partner closely with the Oncology Lifecycle team to define customer requirements, develop tailored plans, and design development strategies targeting specific market segments. In this role, you will establish goals, set high standards for the assay development team, and foster an innovative and efficient environment to support the rapid advancement of high-quality products. The Opportunity Leadership & Team Management: Direct and oversee a team engaged in the development of analytical methods critical to the manufacturing of products and processes. IHC Expertise: Lead IHC Assay development across all project phases, ensuring adherence to V&V requirements and regulatory standards. Strategic Oversight: Collaborate with leadership and stakeholders to plan, resource, and deliver analytical milestones within timelines and budgets. Operational Excellence: Refine team procedures, maintain key laboratories and equipment, and ensure compliance with health, safety, and Roche standards. Performance Development: Hire, train, mentor, and develop team members to support individual career growth and team success. Collaborative Focus: Foster an open, innovative, and collaborative environment during process and assay development efforts. Stakeholder Engagement: Partner cross-functionally to ensure alignment with company objectives and project commitments. Program Management: Ensure milestones, timelines, and deliverables are met for development and on-market support projects. SAFe Agile Execution: Serve as a Product Owner in a SAFe Agile environment, driving team execution and priorities. Leadership Participation: Actively contribute to the OAD Leadership Team and other strategic initiatives.

Requirements

Possess a Bachelor’s Degree in Chemistry, Biochemistry, or a related biological science discipline.
Minimum of 3 years in scientific and product development, with at least 1-3 years of direct management experience in an industrial setting.
Demonstrate strong leadership capabilities to effectively motivate, guide, and manage within both matrixed and direct-line environments.
Showcase comprehensive knowledge in developing, implementing, and supporting reagent-based products in FDA/IVDR regulated environments.
Maintain a deep understanding of principles in chemistry, biochemistry, and molecular biology, while exhibiting exceptional verbal and written communication skills to present complex information clearly.
Use creative and professional problem-solving techniques to drive company objectives and achieve milestones effectively

Nice To Haves

Experience with SAFe Agile methodologies is highly valued.

Responsibilities

Direct and oversee a team engaged in the development of analytical methods critical to the manufacturing of products and processes.
Lead IHC Assay development across all project phases, ensuring adherence to V&V requirements and regulatory standards.
Collaborate with leadership and stakeholders to plan, resource, and deliver analytical milestones within timelines and budgets.
Refine team procedures, maintain key laboratories and equipment, and ensure compliance with health, safety, and Roche standards.
Hire, train, mentor, and develop team members to support individual career growth and team success.
Foster an open, innovative, and collaborative environment during process and assay development efforts.
Partner cross-functionally to ensure alignment with company objectives and project commitments.
Ensure milestones, timelines, and deliverables are met for development and on-market support projects.
Serve as a Product Owner in a SAFe Agile environment, driving team execution and priorities.
Actively contribute to the OAD Leadership Team and other strategic initiatives.