Associate Scientist-Product Development-CMC

Job DescriptionAssociate Scientist-Product Development- CMC
Exton, PA (Research)

Responsibilities:

• Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of parenteral, ophthalmic, and other sterile dosage forms
• Participate in media fills for aseptic fill projects
• Assist in the equipment set up, operation, maintenance, cleaning as required for the project
• Perform Environmental Monitoring (EM) of manufacturing areas per applicable SOPs and maintain records
• Assist with manufacturing area maintenance such as area monitoring and qualification, purchase of gowning supplies, purchase of equipment and room cleaning supplies, microbiological monitoring supplies
• Maintain records for personnel gowning qualification
• Execute product development studies under the guidance of supervisor or lead project scientist to support formulation development (R&D), and clinical drug product manufacturing
• Assist lead formulators in activities such as but not limited to, material procurement, data recording and compilation
• Interact/collaborate with other groups/functions (Formulators, Analytical Scientists, Quality Assurance, Material Coordinator, Manufacturing Technicians) to facilitate transfer of knowledge and delivery of drug product
• Requirements:
• Bachelor's of Science degree with 2-6 years work experience in Pharmaceutical Industry or Master's degree in Pharmaceutical Sciences, Polymer Chemistry, Microbiology, or Chemical Engineering with 0-4 years work experience
• Hands on experience in Pharmaceutical manufacturing per GMP compliant procedures
• Familiarity and working experience with aseptic processing, sterile gowning procedures and qualification
• Strong written and verbal communication

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.