Thermo Fisher Scientific Director, Analytical Development - Biologic Drug Substance in St. Louis, Missouri
The Director, Analytical Development is a key leadership role which manages a large team of scientists across two locations in Princeton, NJ and St. Louis, MO. This role serves as a consultant and technical expert to executive management and is responsible for defining and implementing the Analytical Development strategy for the Biologics (Large Molecule Drug Substance) Business Unit. The Director acts as lead on multiple programs as well as investigates, creates, and implements new scientific methodologies on highly critical, unique and complex projects. You will be responsible for planning and managing significant technical/scientific project activities to execute strategies and technical solutions that meet customer needs and expectations. You will also lead technical discussions with clients and/or regulators as well as manage the design of complex processes and problem solving.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; enabling staff to succeed personally while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Leads high-level design of major experimental plans.
Conducts highly complex analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot challenges.
Sets guidelines for recording of results and reviews documentation by others.
Oversees preparation of protocols, reports, test methods, and SOPs.
Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences. Researches and publishes papers.
Experience & Education:
Minimum 12 years of directly related experience in Technical Development within Biologics Drug Substance Manufacturing
Master's or PhD degree in biology, chemistry, biochemistry, chemical engineering, or a related field is required
Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines.
Thorough knowledge of regulatory issues and the impacts on discipline.
Expert in GMP/ GLP regulations within the cGMP/ cGLP manufacturing environment.
Excellent problem solving and critical thinking skills.
Superior writing, communication and presentation skills.
Ability to drive functional, technical and operational excellence.
Inspires and fosters innovation, collaboration, transparency and team effectiveness.
Designs complex studies based on known deliverables.
Authors reports, procedures, and other documents.
Effectively functions within a rapidly changing environment.
Ability to apply complex mathematical concepts to physical problems in areas.
Performs all process steps and guides on-the-floor manufacturing operations of all process steps as needed.
Applies complex mathematical concepts to physical problems in areas such as heat and mass transport.
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.