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Pharmaceutical Development Scientist II
CATO SMS
Cary, USA
Full-time
Mid
Onsite
Discovered 1 weeks ago
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Responsibilities
- Develops, designs and monitors pharmaceutical development (CMC) activities to meet regulatory agency and client requirements.
- Areas of planning and oversight include analytical methods, preformulation, formulation, manufacture, scale-up, validation, packaging, labeling, distribution, and blinding of clinical materials as well as identification, selection, and management of suitable third-party manufacturing and laboratory service providers.
- Responsible for management of staff scientists and specific project teams.
- Provides CMC regulatory expertise including preparation and review of regulatory documentation as well as participation at various regulatory agency meetings.
- Contributes significantly to strategic and CMC related discussions and associated documents regarding drugs, biologics, or medical devices development, with primary emphasis on product development aspects.
- Performs GMP and GLP audits of various third party manufacturers and laboratory service providers.
- Assists in the evaluation of potential technologies and in the preparation of business development proposals.
Qualifications and skills
- 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. The ideal candidate will be a Ph.D. level scientist with previous experience in the development, manufacture and analytical testing of small molecule or biopharmaceutical products. Ideally this would include development and manufacture of products such as therapeutic vaccines, antibodies, peptides, proteins, and antibody drug conjugates, etc. utilizing various expression systems, i.e. microbial or mammalian.
- Demonstrates attention to details. Plans and organizes with little supervision.
- Proficiency with various computer applications such as Word, Excel, and Power Point, required.
- Equal Employment Opportunity and Affirmative Action
- Cato SMS 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 SMS 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.
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