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Staff Scientist

Job Description SummaryThe Staff Scientist will join the Micro ID/AST Technical Support Group for the Diagnostic Systems Micro Business Unit. The ideal candidate will have project management skills and manufacturing experience of medical devices or pharmaceutical products. She/he will direct projects ranging from technical problem resolution, product quality investigations, supplier qualification, process development and validation, and technology development and transfer from R&D to Manufacturing.
Staff Scientists are responsible for planning and executing individual experiments. They are expected to be independent and are capable of planning and performing a wide variety of experimental techniques with only minimal supervision. They are responsible for data generation as well as data analysis. This data may be presented in departmental as well as interdepartmental scientific meetings. Written and oral reports pertaining to their data and its interpretation are expected. In addition, they may be responsible for the supervision of Scientists I, Scientists II, and Senior Scientists.
Job Description
Staff Scientists are responsible for planning and executing individual experiments. They are expected to be independent and are capable of planning and performing a wide variety of experimental techniques with only minimal supervision. They are responsible for data generation as well as data analysis. This data may be presented in departmental as well as interdepartmental scientific meetings. Written and oral reports pertaining to their data and its interpretation are expected. In addition, they may be responsible for the supervision of Scientists I, Scientists II, and Senior Scientists.
DUTIES AND RESPONSIBILITIES
1. Applies expert knowledge in scientific/engineering theories to execute overall project assignments. Contributes significantly to the projects in the area of specialty through original suggestions and is able to realign project objectives within a reasonably short time frame if project redirection is required.
2. Conceptualizes, prioritizes and schedules project deliverables. Determines trade-offs between product features, product delivery and resource availability. Maintains technical liaisons with individuals within and outside the organization with the responsibility for acting independently on technical matters.
3. Interprets experimentation results to determine appropriate course of action. Acts as a sounding board for testing scientific hypotheses and as a stimulus for the attainment of the highest caliber of scientific thinking and experimentation.
4. Develops and/or directs experimentation.
5. Leads and works effectively with cross-functional teams (Regulatory, Quality, Research & Development and Operations).
6. Formulates and conducts systematic investigation of product and process problem areas.
7. Plans, trains, schedules, carries out and/or directs projects and/or people in assigned disciplines of strategic importance. Provides technical and/or managerial guidance.
With minimum guidance, plans and executes experiments, including the analysis and interpretation of the data, and based upon the conclusions, is able to plan appropriate follow up experiments. Summarizes relevant work into written reports that synthesize experimental results into a working hypothesis and details future plans. Establish and implement SOPs for manufacturing process, manufacturing equipment, assays and troubleshooting protocols. Prepare and deliver functional presentations. Interface with other departments, other facilities and corporate partners to facilitate product development. May participate in the hiring, supervision, development and performance reviews of Scientists I, II and Senior Scientists.
MINIMUM QUALIFICATIONS
Specialized knowledge and skills:
Demonstrates working knowledge and practical ability in a variety of complex laboratory procedures, established techniques, instruments and equipment. Understands the theory of measurement, sources of error, and comparative advantages of different methodologies. Demonstrates specialized technical knowledge acquired through education, training, and/or experience. Knowledge of diagnostic product development and instruments systems and manufacturing is essential. Keeps abreast of laboratory results or current developments affecting assigned project or area of responsibility. In addition, is responsible for understanding key issues related to projects in their department. Experienced investigating and implementing effective solutions consistent to QSR, ISO, and cGMP guidelines. Experience developing or improving manufacturing processes for medical devices or pharmaceutical products. Six sigma and/or lean certification and good working knowledge of applied statistical analysis preferred. Proficient with MS office suite, Access database tools, and Minitab or other statistical software a plus. Effective written and oral communication skills, including data and results presentation to team members.
Education and Experience:
Minimum of MS degree in Microbiology, Biochemistry, Chemistry, Biochemistry, or other related discipline or BS with an equivalent combination of education and experience. Prior experience with ID/AST systems a plus. Experience developing or improving manufacturing processes for medical device or pharmaceutical products.
Physical Requirements:
Ability to sit for prolonged periods of time, handling, typing, talking, listening, requiring clear near and midrange vision in connection with performing essential functions. Ability to travel within the U.S. and possibly overseas. Ability to work inside a laboratory.
Primary Work LocationUSA MD - Baltimore
Additional Locations
Work Shift1st Shift 830am-5pm (United States of America)

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