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Principal Scientist-Product Development
ZipRecruiter, Exton, Pennsylvania, United States, 19341
Job DescriptionJob Description
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 , , , , , , , , status as a protected veteran, among other things, or status as a qualified individual with disability.
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 , , , , , , , , status as a protected veteran, among other things, or status as a qualified individual with disability.