Principal Scientist-Product Development

Principal Scientist-Product Development, CMC Formulation

Location:

Exton, PA (CMC)

Full-time

Frontage Laboratories

Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.

Position Summary:

The Principal Scientist, Product Development is responsible for leading a team of scientists supporting R&D formulation and process development leading to clinical trial material (CTM) manufacturing of pharmaceutical products for IND filing, Phase-I, Phase-II, and ANDA product development.

Responsibilities:

• Manage a team of scientists and project leaders for multiple projects at various stages of product development, including pre-formulation, formulation and process development
• Incorporate Quality-by-Design (QbD) initiatives in the product development program
• Provide technical training, guidance, and hands-on training to junior scientists for study planning and execution leading to development of non-sterile and sterile dosage forms
• Write, review and approve product development report (PDR) and interface with CTM Manufacturing Team for transfer of knowledge for CTM Batch Manufacturing
• Manage project related scientific/technical activities, project management and communication with project sponsors to meet their expectation, and to ensure project timelines
• Collaborate with cross functional teams (Analytical Scientists, Quality Assurance and Manufacturing Technicians) to ensure proper project execution

Requirements:

• Master's in Pharmaceutics, Chemistry, Polymer Chemistry or Chemical Engineering, with 7 - 10 years of experience, or PhD with equivalent experience
• Hands on experience in pharmaceutical product development for IND and ANDA. Manufacturing experience per cGMP compliant procedures is a plus
• In-depth knowledge of theory and techniques in pharmaceutics and drug delivery
• Excellent written and verbal communication and presentation skills
• Excellent people skills
• CRO experience is a plus.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.