Organon - Drug Product Analytical Support and Analytical Stewardship - Womens Health products
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.
Organon Analytical Sciences has an exciting opportunity for a Principal Scientist supporting Women’s Health Products. The incumbent will be responsible for:
Serve as an individual contributor and team leader to support Commercial and Innovative Women’s Health drug products.
Serve as a deep subject matter expert (SME) and point of contact for analytical investigations and analytical method development and validation, product and process characterization questions, registration specification development, drug product stability studies, shelf life establishment, process scale-up and process validation support, and preparation and review of relevant CMC documents for global registration renewals, new product registrations, and responding to regulatory inquiries.
Effective interaction with other technical, regulatory, research and manufacturing groups is critical.
The incumbent is required to work with teams comprised of scientists and non-scientists to effectively and lead the analytical support strategy for multiple women’s health projects.
The incumbent is also expected to mentor other scientists in a matrix relationship well as build/maintain the scientific capabilities of our organization.
To be considered for this position, the incumbent must be an accomplished scientific leader with outstanding problem-solving skills and the ability to work in an interdisciplinary team environment. The candidate must possess strong verbal and written communication skills as well as significant experience in the analytical support of women’s health products. Effective planning and execution of scientific and regulatory strategies and analytical investigation experience a must.
Education Minimum Requirement:
PhD in Chemistry or other physical sciences with a minimum of 7 years of experience, or a BA/BS/MS in Chemistry with at least 10 years of relevant pharmaceutical development experience
Required Experience and Skills:
Outstanding problem-solving skills
Ability to work in an interdisciplinary team environment
Strong verbal and written communication skills
Significant experience in analytical problem solving
Significant experience supporting women’s health products
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at email@example.com