Director Assay Development Jobs

Keep current with all regulatory guidelines, compendia requirements, and technical innovations.

Strong knowledge of virus, protein and DNA/RNA chemistry

Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP)

Demonstrated verbal and written skills in technical reports and documents

Experience in separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric in analyses of biologics

Experience in statistical analysis using JMP or other software

Strong interpersonal skills and excellent project management, data analysis, time management and people skills together with a sense of urgency.

Support the quality management system and review for approval other quality system documents as applicable.

In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques

Manage dynamic timelines, and processes across the product development activities, specifically bioengineering and genome sequencing and cDNA hybridization.

Support all applicable regulations including but not limited to FDA, ISO, IVDR, MDCG, and CMDCAS requirements.

Minimum of 5 years of relevant industry experience and IVD assay development

Demonstrated technical leadership and project management skills;

Experience developing assays, independently designing experiments, and analyzing data;

Fifteen or more years of relevant experience (to include post undergraduate academic or industry experience);

Experience with plant, insect and/or fungi interactions;

Automation experience with mechanical aptitude for operating and troubleshooting automated equipment;

Working knowledge in programming (Python, MATLAB and/or R or similar software);

Proven leadership and managerial experience in multi-functional and matrixed teams

10+ years experience as a research scientist in academia or industry

Experience in the development of new analytical characterization methods for biomolecules/vaccines. Familiar with a broad range of analytical instrumentation and techniques.

Lead a team of PhD and Masters Scientists in the establishment and transfer of immune assays for downstream validation and testing.

Expert in state of the art immune assessments for bacterial and viral targets

Work closely with global project teams and immunology team leads

Demonstrated experience in implementing a successful, world-class pan-cancer early diagnostics program

Review every scientific report, proposal, and work order produced by the Program in a timely and efficient manner

Efficiently respond to suggestions for assay improvement from the ICR Director and ICR Cancer Lab Head

The ability to work in the United States without sponsorship

With us, you’ll get to:

Please apply if you have:

Project management capabilities with excellent problem-solving ability and innate attention to detail

Provide scientific leadership as part of a team of developers to further expand the commercial assay offering

Bachelor’s degree in biological sciences (or a related field) + 8 years of relevant experience, or:

Master’s degree + 5 years of relevant experience, or:

PhD in related field and up to 5 years of relevant experience is required

Experience in developing immunoassays (or related methods), preferably within an industry setting

Ability to efficiently manage scientists, technical goals, and business objectives in parallel is a must

Aligns with Marketing and Sales on new product requirements and commercialization activities.

Must be consistent with a Ph.D. level education

Good problem solving, judgment and decision-making skill are required.

Has an open mind, is willing to try new approaches to overcome challenges, and makes data-driven decisions

Works closely with the Clinical, Regulatory and Quality departments for successful clinical studies, regulatory submissions and design control processes.