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Analytical Development Chemist
4 maanden geleden
The (Scientist 1, Research and Development) is a crucial role supporting the expansion of the Analytical Development (AD) Team and the R&D Organization within Drug Product Development - Europe.
This is a mid-level technical role reporting to the Analytical Development Supervisor. This role also includes responsibilities as core team member that is actively involved in multifunctional project teams that support the growth of Thermo Fisher’s internal product pipeline, external client-based product development, and technical support for on-site operations. This is an excellent opportunity for scientific professionals with experience developing and validating analytical methods within a GMP/GLP environment.
The role plays an essential role the product and technology innovation strategy by leading, executing, and supporting all analytical development activities (method development, validation, stability, data interpretation, problem solving). You will perform laboratory tasks in accordance with applicable procedures and good documentation practices in compliance with GMP requirements. Knowledge of relevant regulatory guidelines can be a benefit. You will work with analytical scientists of various levels and will represent the AD team in various internal and client development projects in all phases of development cycle. The role will be able to continuously improve your customer-facing skills by understanding the voice of the client in the development project teams.
What will you do?
Represent the AD team as core team member in projects to present and discuss solutions for clients and in-house development projects with authority to make decisions on timeline, execution and define the strategy of AD-related activities and results. In addition, you will also coordinate/complete sample testing activities and assist your fellow scientists on performing laboratory benchwork and data analysis to meet project timelines.
Work closely within the R&D matrix organization, collaboration with multiple departments such as project management, formulation, regulatory affairs, process technology and scale-up and validation.
Perform method assessment and establishment activities with senior scientists that includes activities for phase appropriate validation, initial stability assessment for early formulation work, and FDS.
Find the best scientific strategy to characterize the quality, safety, and efficacy of our products.
Telling the story to drive decision-making: present scenarios and recommendations by ensuring that all analytical activities are focused on answering questions that lead to better decisions and high-quality products for our internal and external clients.
Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
Collaborate with peers and perform laboratory activities for analytical method development, validation, and transfers.
How will you get here?
Bachelor of Science or Master’s degree in chemistry, biochemistry or related physical science. Advanced degree preferred.
Typically requires experience (2+ years) working in the pharmaceutical industry, preferably in development. Equivalent combinations of education, training, and relevant work experience may be considered.
Preferably skilled in various analytical techniques ( (U)HPLC) to conduct analysis for stability studies, release of products, and R&D activities
A passion for the use of scientific methodology in enabling method development strategies and solving problems.
Demonstrable knowledge of subject matter(s) related to analytical method development and validation, along with a sound understanding of principles and concepts in other relevant subject areas.
Able to shepherd projects with medium complexity to completion by getting help from others as an individual leader and contributor.
Ability to optimally determine goals, priorities and time required. Can indicate courses of action, required resources, bring up potential issues, and make adjustments as needed to achieve particular goals.
A person who enjoys working in a team, embraces the sophisticated challenges that are related to product development discover satisfaction in this role.
Diversity in our teams is an important element to create an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key characteristics that we expect of all that are part of our community.
Anyone that is already challenged by this position or first would like to know more about it is highly encouraged to respond to this vacancy. This will enable us and you to find out whether you might be the colleague that we are looking for and providing you the opportunity to grow and develop yourself with your contribution in our mission to serve our customers.
We offer
Excellent career opportunities within a large and growing global employer.
Competitive salary.
Annual Incentive Plan (bonus).
Generous benefits package.