Sr. Scientist, Assay Development

Roche Holdings Inc.; California, Carlsbad (MO, CA); On-site; USD 94,000 - 175,000; Full time

Job summary

Join a leading company as a Senior Scientist in R&D Assay Technology Development. You will innovate and develop next-generation molecular biology technologies for IVD products, collaborating with experts to enhance diagnostic solutions. This role offers a dynamic environment with opportunities for professional growth and impactful contributions to healthcare.

Qualifications

• PhD with 3+ years or Master's with 4+ years in product development.
• Extensive experience in IVD product development.
• Mastery in data analysis and bioinformatics.

Responsibilities

• Lead cross-functional teams to develop new IVD products.
• Supervise drafting of regulatory documentation and SOPs.
• Independently develop new molecular biology methods.

Skills

Problem Solving

Data Analysis

Research Design

Bioinformatics

Communication

Education

PhD in Molecular Biology

Master's in related discipline

Bachelor's in related discipline

Tools

JMP

R

Job description

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

We advance science so that we all have more time with the people we love.

GenMark, a member of the Roche Group, is dedicated to providing world-class solutions for multiplex testing, with enhanced features that contribute to Roche's commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the world's #1 diagnostics provider, the Roche Group offers an unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

As a member of our R&D Assay Technology Development team, the Senior Scientist will identify and develop next-generation innovations for on-market and future platforms. The role involves partnering and leading closely with internal scientists, engineers, and external partners to develop protocols for microfluidic consumable and assay development. The Senior Scientist will work cross-functionally to drive product, process, and tool improvements, ensuring scientific, engineering, and analytical best practices are utilized. The individual will be responsible for identifying, developing, and inventing new molecular biology technologies for highly multiplexed molecular IVD products. You should possess strong technical knowledge and practical experience in developing state-of-the-art molecular biology tools (e.g., nucleic acid extraction chemistry, nucleic acid amplification technologies, gene editing, CRISPR, protein engineering) to build highly multiplexed molecular IVD products. You will plan, execute, and analyze cutting-edge technologies that will lead to the development and integration of new molecular diagnostic assays and manufacturing process improvements, creating the next generation of syndromic molecular diagnostics.

• You will work cross-functionally as a hands-on technical leader to develop new IVD products.
• You will perform early development on new technologies for future platforms.
• You will lead, manage, and organize projects and junior staff, tracking deliverables.
• You will lead within a multidisciplinary project team to integrate assays into current and future platforms.
• You will independently identify, invent, and develop new molecular biology methods and technologies (e.g., nucleic acid extraction chemistries, amplification methods) for assay and product development.
• You will supervise system characterization activities of current and future platforms.
• You will supervise the drafting and publishing of data summaries, reports, regulatory documentation, SOPs, and procedures for internal and external stakeholders.
• You will effectively communicate experimental results and propose new strategies to address technical issues to stakeholders.

Who You Are:

(Required):

• You have a PhD in Molecular Biology, Biochemistry, Microbiology, or related discipline with 3+ years of professional product development experience after graduation; or a Master's with 4+ years; or a Bachelor's with 6+ years of relevant experience.
• You have demonstrated success working cross-functionally to investigate new technologies, ideate solutions, and implement ideas into products.
• You have extensive experience in IVD product development, with expert knowledge of new technologies and a problem-solving mindset.
• You possess mastery in data analysis, research design, bioinformatics, and application of new techniques.

Preferred:

• A PhD in Molecular Biology, Biochemistry, Microbiology, with 3+ years of industry experience is preferred.
• You have experience with statistical analysis and DOE tools (JMP or R preferred).
• You are familiar with Quality Management Systems and FDA documentation.
• You have experience with electrowetting movements and microfluidics.
• You are hands-on, self-directed, organized, and able to work tactically and strategically.
• You have strong communication, presentation, and influence skills.
• You possess good time management and organizational skills in a dynamic environment.

Work Environment

The role is performed in an environmentally controlled facility, involving office and laboratory environments. It may involve exposure to hazardous chemicals, blood-borne pathogens, and automated equipment. The employee may need to sit, stand, walk, lift up to 35 pounds, and have specific vision abilities.

This is an on-site position based in Torrey Pines, CA, with travel to Carlsbad, CA. No relocation benefits are provided.

The salary range is $94,000 - $175,000, based on experience and other factors, with potential discretionary bonuses. Benefits are available as detailed in the provided link.

Who We Are

GenMark, now part of the Roche Group, employs over 100,000 people worldwide, advancing healthcare through innovative diagnostics and solutions. Headquartered in Carlsbad, California, GenMark’s ePlex system offers solutions to improve patient care, reduce costs, and increase lab efficiency.

GenMark is an equal opportunity employer, committed to diversity and inclusion. Accommodations are available for applicants with disabilities through the designated contact form.