Senior Application Scientist
Location: Sacramento, CA
Senior Application Scientist
Microbiology diagnostics is a growing market due to the increasing need for rapid testing to combat antibiotic resistance. Increasing demand for automation, and new disruptive technologies such as mass spectrometry are helping laboratories meet this challenge. The Microbiology MicroScan business unit of Beckman Coulter, located in West Sacramento, Ca. is focused on continued delivery of high quality results through our MicroScan portfolio that delivers highly accurate bacterial identification and antibiotic susceptibility testing.
As a key member of the Technical Publications team at the Microbiology business unit, the Sr. Applications Scientist initiates, designs, develops and implements product design improvements and changes for product labeling and instructions for use manuals using design control procedures.
Essential Duties and Responsibilities
MicroScan is looking for a talented Senior Application Scientist, preferably with a medical device or clinical microbiology laboratory background, to partner cross functionally within the organization to create and maintain a variety of Microbiology reagent/consumable Instructions for Use (IFUs) manuals and product labels.
The ideal candidate will be able to gather and document labeling requirements, interview product developers, technical support and marketing managers to obtain necessary information, and distill this information into detailed, accurate, professional documentation. The Senior Application Scientist role is key to our customer’s use of our products and satisfaction. In addition, you will be responsible for preparing, tracking, and finalizing document translation projects as required.
In this role you will:
- Use design control processes to identify and define labeling requirements and provide traceability;
- Maintain documentation in a standard format following established guidelines.
- Review documents for style, clarity, grammar, and punctuation.
- Identify and correct inconsistencies of thought, development, or organization and confer with Subject Matter Experts to recommend an appropriate adjustment.
- Identify labeling translation requirements, prepare and manage translation projects to completion working with our Translation Coordinator.
- Proofread and edit the work of other writers.
- Continuously evaluate business processes, identify improvement opportunities, and implement improvements
- Participate in cross functional projects; lead labeling activities; review project documentation; assess necessary resources and estimate timelines for documentation development, review and translation.
- Track and implement change requests, anomalies, issues, and requirements logged against user documentation.
- Collaborate with development sciences, engineering, marketing, regulatory affairs, and technical support personnel, among others, to ensure accuracy and completeness of labeling. Facilitate review meetings if necessary.
- Leads projects to improve departmental processes that require cooperation from other functional groups
- Remains current on developments in and knowledge of the company's products, markets, policies, and objectives, including regulatory requirements and restrictions
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees and customers.
- Keeps department manager up to date. Seeks guidance on resolution of complex issues.
- Prioritizes work load to manage competing demands, ensures timeliness and objectives are achieved.
Key Skills and Competencies:
Key capabilities include self-motivation, leadership, results-oriented, influencing others, anticipate and respond to business needs, demonstrated teamwork, and ability to identify and bridge gaps.
- Experience as a technical writer, preferably in a medical device company or clinical laboratory. Strong scientific or microbiology background required.
- Must possess excellent oral and written communication skills; organizes and presents ideas in a convincing and compelling manner. Ability to effectively communicate at multiple levels in the organization
- Strong organizational and follow-up skills, as well as attention to detail
- Experience with ensuring, maintaining integrity and quality through demonstration of accuracy and thoroughness. Looks for ways to improve and promote quality. Monitors own work to ensure quality. Applies feedback to improve performance.
- Ability to write/update, review format and manage finalization/release of use/customer documentation (i.e. reagents) according to departmental styles and standards.
- Outgoing personality; self-starter able to work interactively and independently as part of a cross site team with minimal supervision, and manage and prioritize work across multiple work streams of a large program.
- Capable of achieving productivity standards. Completes work in a timely manner. Strives to increase productivity.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to coordinate projects involving input from multiple participants.
- Quick learner of new complex technologies
- Ability to leverage and/or engage others to accomplish projects
- Problem solver – Solves routine issues; identifies non-routine issues and may take actions to resolve. Works well in group problem solving situations.
- Proficiency in Microsoft Office applications (e.g., Word, Excel, Project, PowerPoint) and Adobe Acrobat.
- Understanding of Clinical Microbiology and reporting of appropriate drug therapies is a plus.
- Licensed Clinical Laboratory Scientists or Clinical Microbiologists highly encouraged to apply.
- Bachelor’s degree in field with 5+ years experience OR
- Master’s degree in field with 3+ years experience OR
- Doctoral degree in field with 0-2 years experience