What are the responsibilities and job description for the Pharmaceutical Development Scientist I position at Allucent US LLC?
CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.
We are currently recruiting for a Pharmaceutical Development Scientist I to join our team in the Cary, NC location. The Pharmaceutical Development Scientist I is responsible for managing the pharmaceutical development activities for various drug, biologic or medical device products. Responsibilities may include drug substance synthesis, preformulation, formulation, manufacture, scale-up, process validation, analytical methods development and validation, packaging and labeling. The Pharmaceutical Developmnet Scientist I conducts GMP and GLP audits of contractors including analytical laboratories, manufacturing, and packaging and labeling facilities, participates in FDA teleconferences and meetings, and prepares CMC-related regulatory submissions, including INDs, NDAs, 505b2s, and BLAs.
Responsibilities:
- Write regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
- Guide the writing of regulatory/scientific documents written by other project team members
- Serve as scientific reviewer of regulatory/scientific documents in specific areas of technical expertise
- Contribute significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
- Assist in the evaluation of potential technologies and preparation of business development proposals with primary emphasis on scientific aspects
- Assist in the development and management of projects
- Receives general instructions on routine work and detailed instructions on new assignments
- Applies company policies and procedures to resolve a variety of issues
Qualifications:
- Requires a R.Ph. M.S., Ph.D., or equivalent degree, in a scientific area, or B.S., degree in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Skills:
- Critical thinking and analytical skills, as well as strong written and verbal skills in English
- Scientific and regulatory knowledge of drug, biologic, or device development, desirable
- Minimum of 2 years’ post-degree of directly relevant experience in drug, biologic, or device development, desirable
Equal Employment Opportunity and Affirmative Action
Cato Research LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Cato Research, LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.