Director Assay Development Jobs

You will be responsible for directing projects to develop and commercialize molecular diagnostic assay products on the ePlex sample to answer platform. In this role, you will have assay development functional responsibility as well as cross-functional responsibility in support of technical transfer and regulatory submissions. Reporting to the VP of Assay Development, you will lead a team of employees ranging from scientists, research associates and/or assay development managers in Assay Development. This position will be located at the company's headquarters, in beautiful Carlsbad, CA (north county San Diego).

POSITION REQUIREMENTS

• Ability to efficiently manage scientists, technical goals, and business objectives in parallel is a must
• Leads a team of scientists and research associates in assay design and optimization, as well as provides troubleshooting support to on-market products
• Builds and provides leadership for an effective team in a high growth environment including hiring, on-boarding, developing, goal setting, performance improvement and disciplinary actions.
• Aligns with Marketing and Sales on new product requirements and commercialization activities.
• Strong sense of pragmatism, enterprise mindset, time management, ability to focus team members and prioritize work tasks to meet deadlines in a rapidly evolving environment are critical
• Directs and manages multiple teams to develop assays for future ePlex® products. Drives cross-functional teams to deliver new products to specifications, on time and on budget.
• Cooperates with manufacturing and supply chain to facilitate effective transfer of assays to manufacturing.
• Provides an open environment and promotes teamwork across the organization.
• Works closely with the Clinical, Regulatory and Quality departments for successful clinical studies, regulatory submissions and design control processes.
• Has an open mind, is willing to try new approaches to overcome challenges, and makes data-driven decisions

Education and Experience

• The ideal candidate will have expertise in genomics and molecular biology, including principles of nucleic acid hybridization, probe and primer design, molecular cloning and technologies for amplification of specific gene sequences.
• Prior experience designing & developing nucleic acid-based "sample to answer" molecular diagnostic products within a regulated environment, utilizing design control process required.
• Sound knowledge in verification & validation activities, as well as clinical studies in pursuit of FDA clearance. Significant contribution to the successful clearance of an FDA regulated medical device.
• Minimum of (10+) years of experience in medical diagnostic product development, with (5+) years managing scientific teams as an R&D Manager/Director, ideally within a MDx company.

Skills – Technical

• Prior experience designing & developing nucleic acid-based "sample to answer" molecular diagnostic products within a regulated environment, utilizing design control process required.
• The ideal candidate will have expertise in genomics and molecular biology, including principles of nucleic acid hybridization, probe and primer design, molecular cloning and technologies for amplification of specific gene sequences.

Skills – General

• Must be consistent with a Ph.D. level education
• Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Good problem solving, judgment and decision-making skill are required.
• Must be proficient in writing, and communicating in the English language.
• The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.

SUPERVISORY RESPONSIBILITIES (if applicable)

• Will lead a team(s) of employees ranging from Research Associate to Manager, and will coordinate efforts of the department with those of senior technical staff and management from other departments.

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

Relocation benefits are offered for this role. The expected salary range for this position based on the primary location of Carlsbad, CA is $181,040 and $237,615. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed here: Benefits

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.