Senior Scientist - QbD Lead

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Durham NC - Remote

The Senior Scientist QbD will report to the Head of Quality by Design and Quality Analytics and will be responsible for the management of the Quality operations made up of multiple sites within the PSG division This position will lead both direct organizational reports and matrix reporting quality personnel to ensure compliance with industry and regulatory standards and customer expectations for designing quality into products and analytical products used in pharmaceutical/Biologics/Sterile/API manufacturing. As the Head of Quality for this business unit, the role will also focus on ensuring that staff engagement is maintained at a high level through development planning.

What will you do?

+ Provide Quality leadership for the PSG and Quality Analytics Network

+ Help to build Statistical models for product and process adaptability

+ Apply Monte Carlo Simulations on data for build Forecasting Models

+ Helping to incorporate Analytical Quality by Design in Analytical Development

+ Developing and implementing Roadmaps of QbD in OSD/Sterile/Biologics/API product and process development

+ Working with the FDA on Quality by Design issues in products/processes

+ Responsible for Quality oversight across multiple sites based on the organizational design that spans multiple countries

+ Contribute to the strategy and development of the Quality Management System for the PSG and Quality Analytics organization

+ Partner with the operations and commercial organizations to ensure customer fulfillment

+ Manage matrix relationships to ensure compliance of the network

+ Deploy key programs to ensure alignment of the organization to agreed goals

+ Work across multiple product lines and types of manufacturing processes seamlessly

+ Solves problems in complicated situations using analytical skills, creativity, and judgment, and technical expertise with the SUT technology

+ Impact through the delivery of results

+ Communicate internally to senior leaders and diverse audiences

+ Drive resolution to quality complaints (functional defects with components or performance-related failures), and applies Quality Risk Management to prevent the risk of poor quality in product and process development

+ Conduct advanced data analyses to resolve quality problems and identify larger-scale quality improvements

+ Participate in cross-functional team projects (R&D, Mfg., Vendors, etc.). Examples: support new product introduction projects or quality improvement projects, identify the root cause of product-specific defects and apply a risk management approach to mitigate the risk of Quality issues and Quality built-in to the product/process concept

+ Ensure overall program and product quality improvement by guiding other team members in continuous process improvement implementing preventative actions and reviewing lessons learned

How will you get here?

Education

+ Master's degree or above in Science or Engineering Disciplines; MS in Statistics is preferred

Experience

+ 10 years of experience within the Pharmaceutical Industry supporting Regulated Products

+ Previous knowledge of working with the FDA or any other regulatory agencies in specific projects is plus

Knowledge, Skills, Abilities

+ Expert knowledge of Quality by Design and oversight from the pharmaceutical perspective

+ Design of Experiments

+ Quality tools e.g. FMEA, Risk Analysis, etc.

+ Simulation and Optimization Tools

+ Ability to travel and work with external customers and commercial teams

+ Support of Biologics/API or Pharmaceutical New Product Introductions.

+ Strong proficiency in Quality Control methods and validations.

+ Multilingual preferred

+ Black Belt in Lean Six Sigma preferred

Travel:

20% -30%

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.