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Fresenius Kabi USA · 1 month ago

Principal Scientist (Formulation Development)

Melrose Park, IL

Full-time

Onsite

Senior Level, Lead/Staff

$116K/yr - $154K/yr

3+ years exp

Fresenius Kabi USA is seeking a Principal Scientist to complete developmental studies for FDA drug applications. The role involves overseeing product development, implementing experimental programs, and supervising lab staff while ensuring compliance with corporate and GMP requirements.

Health Care

No H1B

Responsibilities

Accepts responsibility for all stages of product development including on-site monitoring of stability lot manufacturing

Plans, develops, and implements scientifically well-designed experimental programs to meet project objectives as well as meeting corporate and GMP requirements

Identifies the multidimensional aspects of complex problems and applies novel and creative solutions to problems. Capable of handling the most complex projects with only general guidance

Participates in the orientation and training of new lab employees in the proper execution of research and development experiments and is responsible for supervising one to two lab staffs

Responsible for product and process improvement as well as for ideas for new products, line-extent, product stability improvement and novel drug delivery systems

Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule and is further accountable for the use of his/ her time for creative, self-initiated research

Qualification

Experimental designPharmaceutical dosage formsNovel drug delivery systemsSafety proceduresProblem solving

Required

Bachelor's degree with 7 years of related experience, or a MS degree with 5 years of related experience, or a Ph. D. with three years of related experience

Must possess skills of designing and executing experiments, analyzing experimental results, and solving problems

Must have knowledge of pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems

Must be willing to perform drug product development for potent compounds, cytotoxic substances and/or controlled substances while following and observing all safety procedures in place, which include the use of engineering controls, administrative controls, Standard Operating Procedures (SOPs), training, and Personal Protective Equipment (PPE)