Location: Maryland Heights, MO
Company: Curium Pharma
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.
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the Laboratory Supervisor. ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following. Management retains the right to add to or change the duties of the position at anytime. The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.
Perform the receipt, compositing, and organization of samples submitted to SORA Labs. Perform sampling in a GMP environment. Perform and report the assigned testing of samples submitted to the laboratory. Perform testing in support of OOS investigations. Perform and report the routine maintenance and calibration of equipment and instrumentation. Record and peer-review
analytical and calibration work performed as required for GMP and laboratory accountability. Organize and maintain the necessary chemical and reagent stocks. Maintain the laboratory facilities in a clean and organized manner.
Properly handle and dispose of all hazardous waste generated during routine functions. Cross-train and assist others in performing routine testing of submitted samples. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Possess expertise and proficiency with analytical
laboratory glassware, equipment and instrumentation. Be able to read, analyze, and interpret methods and standard operating procedures.
Be able to use aseptic technique when required. Be able to work independently in an organized and reliable manner Be willing to work extended hours, weekends and holidays when needed. The position requires extensive standing. The employee is regularly required to walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. EDUCATION AND/OR EXPERIENCE: Requires a Bachelor of Science in Chemistry, Biochemistry or related field. 0 to 3 years' experience preferred. WORK ENVIRONMENT: Work is carried out in an analytical laboratory.
There is considerable exposure to raw materials and chemical reagents. Personal Protective Equipment such as lab coats, gloves, safety glasses and respirators must be worn as defined by safety policy. TRAINING REQUIRED: per SOP# SORA-152-010This position offers a complete benefit package, including 401K/ESOP, pension, health, life and dental insurance. ADM requires the successful completion of a pre-employment drug screen and a background check. REF:76543BR " AJCIND"
accessibility, single-cell RNA sequencing, bulk RNA sequencing, small RNAs, RNA modifications, metagenomes, metabolomes, genome-wide association, and epigenome-wide association), and develop necessary pipelines to discover biomarkers of inherited non-genetic diseases and pathways to the disease, including using the artificial intelligence approach.
Dr. Bhandari's research concerns the intra-, inter-, and transgenerational inheritance of environmentally induced adverse health outcomes and mitigation of reproductive and metabolic health crises in subsequent generations by blocking the pathways to the disease. His research group has demonstrated using medaka fish that environmentally induced
non-genetic imprints can be transmitted vertically from one generation to another across several generations. Using state-of-the-art techniques of epigenome editing (CRISPR-d Cas9), the group is striving to remove non-genetic imprints and understand their role in the onset and progression of the observed reproductive and metabolic health abnormalities.
Qualifications Minimum Qualifications: A Ph. D. in bioinformatics, computer science, or biological sciences by time of appointment. Candidates will be evaluated on: Experience in the development of bioinformatic analysis pipelines for humans and rare model species Knowledge and skills in machine learning or artificial intelligence in biological
and biomedical sciences Experience in analyzing large data sets and statistical analysis.
Application Materials Use the online application and be prepared to upload your CV, research statement, and unofficial transcripts (Ph. D. ). Applicants must arrange to have three letters of recommendation emailed directly to Ramji Bhandari at value the uniqueness of every individual and strive to ensure each person's success. Contributions from individuals with diverse backgrounds, experiences and perspectives promote intellectual pluralism and enable us to achieve the excellence that we seek in learning, research and engagement. This commitment makes our university a better place to work, learn and innovate.
In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research and engagement. Applicants may contact the Chair of the Search Committee Ramji Bhandari and with any questions about the job duties. Contact Human Resource Services ( ) for any questions about the application process. Applications will be reviewed starting Nov 27, 2023, and the position will remain open until filled. Benefit Eligibility This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, and educational fee discounts.
For additional information on University benefits, please visit the Faculty & Staff Benefits website at http: //www. umsystem. edu/totalrewards/benefits Values Commitment We value the uniqueness of every individual and strive to ensure each person's success. Contributions from individuals with diverse backgrounds, experiences and perspectives promote intellectual pluralism and enable us to achieve the excellence that we seek in learning, research and engagement.
This commitment makes our university a better place to work, learn and innovate. In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research and engagement. Equal Employment Opportunity The University of Missouri System is an Equal Opportunity Employer. Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, interaction, pregnancy, interactionual orientation, gender identity, gender expression, age, disability, or protected veteran status, or any other status protected by applicable state or federal law.
This policy applies to all employment decisions including, but not limited to, recruiting, hiring, training, promotions, pay practices, benefits, disciplinary actions and terminations. For more information, visit www. umsystem. edu/ums/hr/eeo.
