The Product Development Lead Scientist reports to the Manager of the Product Development group.
St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. ?Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
The Product Development Department is responsible for new product development over the lifecycle of the project which could include benchtop/labscale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. Addition responsibilities may include support of development/commercial product investigations, and technology transfers from other sites to the St. Petersburg, FL facility.
The Product Development contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required formulation and process activities.
If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this might be for you!?
Executes experimental studies intended to provide supporting data or to resolve technical issues encountered during each project. Defines technical objectives and conveys them to other members of the project team.
May represent the Softgel Product Development department at both internal team meetings and customer meetings relating to assigned projects that may be of diverse scope (including other technologies).
Resolves technical issues, makes recommendations for options that would resolve the issue, including a preferred option.
Works independently, supervised on a daily or weekly basis, recognizes key issues likely to affect successful and/or timely completion. For those issues that cannot be resolved, brings them to the attention of the person coordinating the work.
Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety or quality.
Understands revenue associated with each project phase. Flexible with respect to project priorities and ensures that site and/or departmental business objectives are met.
Complete technical activities, development reports and regulatory support documentation as required.
Complies with Health, Safety and Environmental responsibilities for the position.
PhD in Pharmacy/Pharmaceutical Sciences, Engineering, or related science with 7+ years of applicable product development experience required and 5+ years of direct softgel product development experience preferred.
MS/BS in Pharmacy/Pharmaceutical Sciences, Engineering, or related science with 10+ years of applicable product development experience and 5+ years of direct softgel product development experience preferred.
Knowledge Skills: Working knowledge and application of scientific principles and techniques. Exposure to computer software associated with word processing and spreadsheets required with some exposure to statistical software preferred.
Familiarity with batch processing in a pharmaceutical, cGMP environment.
Strong knowledge of cGMP Regulatory requirements for process development, technical transfer, and process changes required.
Effective communication, documentation and writing skills required.
Basic project management skills (deliverables, timelines, resources required) is preferred.
Familiarity with root cause analysis and risk assessment techniques (e.g. FMEA) is preferred.
Cross functional exposure to other areas of Operations?
Medical, Dental, Vision and 401K are all offered from day one of employment?
152 hours of paid time off annually + 8 paid Holidays
We will identify candidates based on the following Catalent Competencies:?
Leads with Integrity and Respect?
Demonstrates Business Acumen?
Fosters Collaboration and Teamwork?
Engages and Inspires?
Coaches and Develops?
Internal Number: 0050068
About Catalent Pharma Solutions
With over 85 years of serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply. Catalent employs over 1 4,000 people, including over 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ.
Mission: Our mission is to develop, manufacture, and supply products that help people live better, healthier lives.