R&D
Senior Scientist - Drug Development
This person will manage outsourced contract development and establish and develop laboratories to allow in-house capabilities for formulation of drug candidates for the development of pipeline products. The role includes responsibility to conduct and oversee evaluation and development of drug formulations in a high-paced environment with cGMP boundaries, and maintain industry contacts and familiarity with existing and new formulation development technologies. The position also involves working closely with other R & D functions, Engineering, Operations, Sales and Marketing to synchronize technology, applications, marketability, and stability of new product opportunities. The position requires maintaining Regulatory requirements and strategy throughout the development, submission, and approval process. Clear, concise written reports to management and interaction with the Legal Department as well as actively engaging in New Business Development projects.
Key Responsibilities:
• Pre-formulation R&D for intranasal and ophthalmic drugs and biologics and delivery of human therapeutics
• Pharmaceutical development in the area of Chemistry, Manufacturing and Control (CMC) to evaluate and develop formulations for existing drugs suitable for ophthalmic and nasal drug delivery and new chemical entities (NCE, small molecule) from research through development. The CMC activities include preformulation analytical development, and formulation development.
• Contribute to the nomination of a new chemical entity for development, by identifying the strengths and weakness of lead chemical candidates and potential impact on formulation and development strategies
• Conduct preformulation experiments such as solubility assessments, pH-stability, and pH-solubility to characterize new chemical entities and devise appropriate formulation strategies.
• Communicate results, devise strategies and resolve development issues in a team environment.
• Assist in developing and managing budgets for CMC activities
• Participate and contribute CMC support and guidance to support discovery research
• Attend and participate in development meetings and scientific meetings to remain current with development technologies and regulatory guidelines pertaining to CMC activities
Qualifications: To be considered for this position the candidate must have a Ph.D. in Chemistry, Biochemistry or a related discipline with at least~5-7 years of formulation R&D experience within the pharmaceutical/biopharmaceutical industry. Verifiable experience in pre-formulation of ophthalmic and intranasal drugs or biologics with a broad understanding of the scientific, regulatory and drug development process from research to commercialization. Must possess in-depth knowledge and experience in drug development processes, formulation development and manufacturing along with quality assurance and regulatory compliance for successful product development and thorough understanding of cGMP including interpretation and application.
To apply for this position, please click here.
This person will manage outsourced contract development and establish and develop laboratories to allow in-house capabilities for formulation of drug candidates for the development of pipeline products. The role includes responsibility to conduct and oversee evaluation and development of drug formulations in a high-paced environment with cGMP boundaries, and maintain industry contacts and familiarity with existing and new formulation development technologies. The position also involves working closely with other R & D functions, Engineering, Operations, Sales and Marketing to synchronize technology, applications, marketability, and stability of new product opportunities. The position requires maintaining Regulatory requirements and strategy throughout the development, submission, and approval process. Clear, concise written reports to management and interaction with the Legal Department as well as actively engaging in New Business Development projects.
Key Responsibilities:
• Pre-formulation R&D for intranasal and ophthalmic drugs and biologics and delivery of human therapeutics
• Pharmaceutical development in the area of Chemistry, Manufacturing and Control (CMC) to evaluate and develop formulations for existing drugs suitable for ophthalmic and nasal drug delivery and new chemical entities (NCE, small molecule) from research through development. The CMC activities include preformulation analytical development, and formulation development.
• Contribute to the nomination of a new chemical entity for development, by identifying the strengths and weakness of lead chemical candidates and potential impact on formulation and development strategies
• Conduct preformulation experiments such as solubility assessments, pH-stability, and pH-solubility to characterize new chemical entities and devise appropriate formulation strategies.
• Communicate results, devise strategies and resolve development issues in a team environment.
• Assist in developing and managing budgets for CMC activities
• Participate and contribute CMC support and guidance to support discovery research
• Attend and participate in development meetings and scientific meetings to remain current with development technologies and regulatory guidelines pertaining to CMC activities
Qualifications: To be considered for this position the candidate must have a Ph.D. in Chemistry, Biochemistry or a related discipline with at least~5-7 years of formulation R&D experience within the pharmaceutical/biopharmaceutical industry. Verifiable experience in pre-formulation of ophthalmic and intranasal drugs or biologics with a broad understanding of the scientific, regulatory and drug development process from research to commercialization. Must possess in-depth knowledge and experience in drug development processes, formulation development and manufacturing along with quality assurance and regulatory compliance for successful product development and thorough understanding of cGMP including interpretation and application.
To apply for this position, please click here.