The Lead Scientist role is a part of our Analytical Stability group in Morrisville, NC.
The laboratory groups at Catalent RTP are responsible for the support of pharmaceutical product development in a range of dosage forms both directly with customers and in collaboration with other Catalent facilities. This includes formulation development, structural chemistry, analytical support, and clinical trials material manufacturing
Under general supervision, the Lead Scientist plans, conducts and leads assignments involving the identification, assessment and development of new scientific concepts and technologies. The Lead Scientist reviews progress and evaluates results, plans and assigns personnel for given projects or tasks, and recommends changes in procedures. The Lead Scientist operates with substantial latitude for un-reviewed action or decision, reviews progress with management, and will comply with divisional and site Environmental Health and Safety requirements.
The Role (daily responsibilities):
Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics
Authors technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures.
Conduct routine stability testing, method transfer and in process testing
Will work cross functionally and have customer interaction
Review technical documents for accuracy, thoroughness and regulatory compliance
Trains, coaches or mentors others on technical, personal development or business issues
Supervises technical staff, including work assignments and performance
Responsible as Project Director with responsibility for project outcome and customer interaction
All other duties as assigned
The Candidate (requirements):
Experience: Bachelor's degree with >10 years related experience, OR Master's degree with >8 years related experience; OR Doctorate Degree with >4 years related experience is required.
Dissolution experience is preferred. Method development and validation experience is a must. Must possess previous experience working in a GMP environment
Must have good documentation skills
Must possess high level knowledge and experience in HPLC technique and theory
Must be an independent worker
Experience with Empower software a huge plus
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually
Opportunity for growth, promotions, development and a robust career path.