Biotech / Pharmaceutical Jobs in Maryland Heights, MO

excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiomedical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine.

The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team. Summary of Position The Senior

Principal Scientist position will report to the Director of Upstream Development. The successful candidate will serve as a key functional core team member and will support the development, commercial implementation and lifecycle management of radioisotopes and radiomedicals.

Work Schedule: Monday - Friday 8:00am - 5:00pm. Working hours could be adjusted. -Essential Functions Design and execute development activities to support CMC generation for NDA/ANDA submissions. Provide technical support for existing radiomedical, isotope, and related cold kit processes. Proficient with analytical techniques used for structural characterization and impurity profiling (including radiochemical and

radionuclidic purity). - Maximize productivity by selecting effective choice of techniques / routes, provide solutions to complex multi-step problems.

Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality. Maintain a high-level of understanding of global (ICH, FDA, EMA) regulatory requirements (in particular Chemistry, Manufacturing, and Controls) including those for filing and approval of investigational and commercial products. - Provide expert peer review on all R&D documentation. Experienced communicator, ability to work cross functionally inside and outside the organization. - Participates in collaborative engagement with colleagues both internal and external to Curium.

Requirements Achievement of a Ph D, Master's Degree or Bachelor's Degree in Chemistry, Chemical Engineering, Biochemistry, or related field. 15 or more years of relevant medical industry experience required. Experience with c GMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations. Experience with cyclotron-based isotopes, and diagnostic cold kits. Experience in achieving regulatory approval of new drugs or medical devices. Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions.

Experience preparing CMC regulatory filings. Radiomedical experience and medical development experience highly preferred. Experience in New Product Development including knowledge of Regulatory Affairs. medical industry experience is required with a strong familiarity with c GMP, FDA, EMA, USP, NRC, and ICH guidelines. - Knowledgeable about the use of New Product Development Processes and introduction of these products to market. Ability to demonstrate a strategic mind-set with the ability to translate strategies into operational plans.

Strong attention to detail with a technical mind-set - accuracy of project completion and application of product knowledge is imperative to success. - Behavioral requirements for success in this position include: self-starter, strong work ethic, excellent written and verbal communication skills. The successful candidate must have the ability to successfully support and potentially manage multiple analytical projects and contribute to team based investigations. Working Conditions: Standard office environment, coupled with approximately 80% time in radiomedical manufacturing and laboratory environments.

Must be willing to wear a variety of personal protective equipment. Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Willingness to work in a team based environment. - May be required to sit or stand for long periods of time while performing duties. - Must be able to work outside of regular work hours. Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.

Must possess good hand-eye coordination. Potential of 10% overnight travel. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Equal Opportunity Employer Curium is an -equal opportunity employer -and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment -without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status.

#J-18808-Ljbffr