Senior Product Development Scientist
Summary of Major Responsibilities
The Senior Product Development Scientist will lead a team of researchers focused on developing new products through new technology evaluation, assay development and optimization, and the identification and implementation of process improvements to existing workflows. This position provides clear direction for work in the department and leads projects that are complex in scope. The Senior Product Development Scientist works collaboratively with others within the department and represents Product Development cross-functionally.
Essential Duties and Responsibilities
- Provides leadership over research associates by establishing employee objectives and development plans, providing coaching and mentorship, and participating in employee performance reviews.
- Continuously researches literature and other sources to maintain knowledge of technological industry developments that may assist in the completion of an assignment or lead to new products, processes or procedures.
- Conducts projects under quality system requirements and adheres to Regulatory guidelines, including Design Control.
- May act as leader for a complex project, including projects involving research collaborators.
- Works with team members and others across the company as appropriate to meet department and project objectives.
- Prepares experimental plans and effectively communicates them to the team.
- Trains techniques and procedures to research associates and scientists.
- Analyzes results, prepares reports and presents data/updates at project or departmental meetings.
- Acts as in-house technical expert on specific technologies or projects.
- Contributes ideas for troubleshooting, process improvements and new product initiatives.
- May attend and present findings at scientific meetings or to customers. May contribute to articles for publication.
- Provides technical input and has great influence in decisions affecting project planning and experimental design.
- Effectively utilizes and applies methods or technologies and develops new techniques when appropriate.
- Insures team lab notebooks are completed properly following all legal, ISO and QSR requirements.
- Works within established project timeframes.
- Performs other related duties as assigned by management.
- Strong, demonstrated leadership experience with at least 3 years of responsibility managing and supervising direct reports.
- Ability to establish priorities, delegate responsibilities, identify and solve performance issues and provide ongoing coaching and support to team members.
- Able to organize, present, and convey complex problems or issues.
- Hands-on experience with molecular biology techniques, particularly real-time PCR assays.
- Advanced knowledge of statistical and mathematical methods in biology/genetics, including experience with JMP software.
- Extensive experience in using basic software applications including Microsoft Office (Word - generate documents and tables, Excel - able to create and modify spreadsheets, create complex formulas, etc.); Email – preferably Outlook; and various search engines for conducting Internet searches.
- Clear communication with supervisor, team members, and Sr. Management.
- Strong verbal and written communication skills.
- Excellent presentation skills.
- Ability to interface and work effectively within team, within department, and with other departments across the business.
- Ability to effectively work on several varied projects at one time, with frequent changing priorities.
- Strong attention to detail.
- Advanced analytical, problem solving and decision making skills.
- Excellent understanding of GMP, ISO, and Quality Systems.
- Effective project and team leader.
- Ability to take ownership of key technical projects and drive them to completion.
- Previous industry experience in Product Development.
- Working knowledge of genomic databases and software.
- Demonstrated knowledge of DNA/RNA purification.
- Background containing a substantial amount of laboratory work including assay development, optimization, and troubleshooting.
- Experience with DOE, test method development, and analytical study design.
- Working knowledge of the Regulatory requirements for FDA submission (e.g., 510(k), PMA, etc.)
- Independent self-starter with positive attitude.
Education and Experience
- Bachelor’s degree in Life Sciences, or related field plus a minimum of 12 years’ experience, or Master’s degree in a Life Sciences field plus at least 8 year of industry experience, Ph.D in a Life Sciences field plus at least 4 years of industry experience.
- Experience working in a molecular diagnostics/clinical laboratory setting preferred.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit for an extended period of time.
- Ability to stand for extended periods of time and up to 6 hours at a time.
- Ability to travel (by land and air), both domestically and internationally, on occasion.
- Ability to frequently and accurately communicate with employees, customers, etc. face-to-face, via the telephone or by email.
- Ability to learn and understand scientific concepts and keep current on the scientific literature and technologies.
- Ability to work with human specimens, including blood, stool, and tissue.
- Constantly moves about to coordinate work.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
Meet Some of Exact Sciences's Employees
As a research scientist on the Product Development Team, Brenda’s core responsibilities revolve around new pipeline projects and process improvements to Exact Sciences’ Cologuard tests.
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