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$30k-56k yearly est. 1d ago
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Regulatory Labeling Scientist
Qualified Professional & Technical 3.8
Research scientist job in Austin, IN
Austin, IN
Direct Hire
Hybrid
$90k with potential to earn more depending on experience
As a Regulatory Labeling Scientist, you will play a key role in guaranteeing that all products meet FDA, USDA, and third-party labeling requirements, while collaborating cross-functionally to support accurate and timely product labeling across the organization.
Position Summary:
The Regulatory Labeling Scientist supports the R&D Manager and Label Regulatory Specialist in the development, review, and management of product labeling. This includes ensuring ingredient and recipe compliance, maintaining SAP label data, and supporting certification and audit processes.
Key Responsibilities:
Ingredient & Recipe Compliance:
Review ingredients and recipes to ensure compliance with all applicable regulations.
Interpret and apply FDA and USDA labeling rules and standards.
Label Development & Management:
Create and manage Nutrition Facts Panels and ingredient statements.
Ensure label accuracy for health and wellness claims and standards of identity.
Maintain and update label data within SAP PLM systems.
Customer & Certification Support:
Collaborate with customers on label artwork, specifications, and approvals.
Manage USDA submissions and third-party certifications (Organic QAI, Non-GMO, Kosher OU).
Support customer label changes using SAP Engineering Change Management.
Cross-Functional Collaboration:
Work closely with Food Safety, QA, Purchasing, and Operations teams.
Assist with audits and regulatory filings to maintain compliance readiness.
Regulatory Leadership & Improvement:
Research and interpret evolving food labeling regulations.
Develop documentation such as white papers and position statements.
Drive continuous improvement in regulatory processes and data accuracy.
Qualifications & Skills:
Bachelor's degree in Food Science, Biology, Chemistry, Nutrition, or related field.
2-5 years of experience in Regulatory Affairs, QA, or Food Safety within the food industry.
Strong understanding of FDA, USDA, HACCP, and food labeling regulations.
Proficiency in Microsoft Office and ERP systems (SAP preferred).
Excellent communication, analytical, and project management skills.
Strong interpersonal and cross-functional collaboration abilities.
Highly organized and able to manage multiple priorities in a fast-paced environment.
Ability to travel as needed.
Physical Requirements:
Ability to stand and walk for extended periods (8-12 hours).
Must be able to lift up to 50 lbs and push/pull up to 100 lbs with assistance.
Ability to bend, stoop, climb, and perform manual handling tasks as needed.
Comfortable working in varying temperature environments (hot, cold, humid).
Must wear required PPE (hairnets, gloves, goggles, etc.).
$90k yearly 2d ago
Formulation Scientist - Dietary Supplement
Pave Talent 4.5
Research scientist job in Winchester, KY
Our client is expanding beyond the CBD space into broader nutraceutical and dietary supplement categories. We are seeking an entrepreneurial Dietary Supplement Formulator to join our team.
This role is critical in supporting the sales team as they build out new business lines; you will be "building the plane while flying it." The ideal candidate thrives in a fast-paced environment with some "gray area," where they must act quickly to support urgent sales requests. You will not be siloed; unlike roles in large corporations, you will handle end-to-end responsibilities including sourcing and costing, as there is no separate procurement team for these tasks.
Key Responsibilities
Rapid Prototyping & Sales Support: Develop rapid-turnaround formulations to support the sales team with realistic, deliverable products.
Cost Analysis & Procurement: Source raw materials and calculate formulation costs independently, as you will not have a dedicated procurement or costing team to rely on.
Cross-Category Formulation: Develop and refine formulations across various delivery systems, including liquids and topicals.
Scale-Up Management: Oversee the scaling of formulas from benchtop to production, ensuring commercial viability and troubleshooting issues as they arise.
Regulatory & Quality: Ensure all formulations meet regulatory standards within an FDA-registered cGMP facility.
Qualifications
Education: Bachelor's degree in Chemistry, Biology, Food Science, or a related field.
Experience: 3-5 years in dietary supplement or nutraceutical formulation.
Technical Knowledge: Strong understanding of active ingredients, delivery systems, and excipients.
Generalist Mindset: Experience wearing "multiple hats" in smaller/mid-sized companies, avoiding siloed function.
Entrepreneurial Spirit: Comfortable with ambiguity and urgent timelines to support sales initiatives.
$52k-75k yearly est. 3d ago
Postdoctoral Researcher In Digital Twins for Health Informatics
University of Kentucky College of Medicine 4.2
Research scientist job in Lexington, KY
We are seeking a highly motivated postdoctoral researcher to join the Zero Knowledge Discovery Lab (**************************** to work on problems at the intersection of biology, medicine, mathematics and computation. The successful candidate will contribute to the development of next-generation learning algorithms to understand human health trajectories through advanced digital twin frameworks, ranging from analyzing the darkome of genomic data to developing digital twins for the human microbiome/metabolome. One of our funded projects that the candidate will work on is MAGICS: Methodological Advancements for Generalizable Insights into Complex Systems funded by DARPA (************************************************************************************************************
The ideal candidate will be an applied mathematician with equally sophisticated skillsets in theorem proving, algorithms and coding.
Requirements:
PhD in computer science, physics, engineering, statistics or applied mathematics is required.
A strong foundation in mathematical modeling. Familiarity with stochastic processes, information theory and discrete mathematics is a plus.
Programming Skills: Proficiency in Python, familiarity with scikit-learn is good, experience in C++ is a plus
Documented Productivity: Record of peer-reviewed publications
Interdisciplinary Interest: Candidates should have a passion for applying computational techniques to solve complex problems across disciplines.
Key Responsibilities:
Mathematical Foundations: Work on the rigorous mathematical foundations of emerging digital twin frameworks, and the theoretical aspects of ML. Example papers: ***************************************** , **************************************************
Research & Algorithm Development: Develop advanced algorithms to predict complex health trajectories, simulating individual patient journeys, and providing real-time dynamic views of patient health. This involves working with multimodal datasets, including EHRs, genetic data, and social determinants of health.
Collaborative Research: Engage with a diverse group of researchers in fields such as computational biology, medicine, and social sciences. Publish findings in top-tier journals, present at conferences, and contribute to the advancement of the field.
Compensation and Benefits:
Competitive Salary: Funding is available for a competitive salary, based on qualifications and experience.
Research Support: Additional funding will be provided for supplies and travel to conferences.
Professional Development: Opportunities for significant career growth, networking with leading researchers, and engaging in high-impact interdisciplinary projects.
Women and underrepresented groups are encouraged to apply.
Please contact Dr. Ishanu Chattopadhyay (ishanu_**********) for application details with CV and github link if available
$43k-57k yearly est. 1d ago
Assistant/Associate/Full Research Professor of Neurology
Indiana University Academic Positions 4.6
Research scientist job in Indiana
The IU School of Medicine ( IUSM ) Department of Neurology is seeking well-qualified and highly motivated applications for a scientist track faculty position. All academic ranks (Assistant to Full Professor) will be considered. Applications will be reviewed on an ongoing basis; start dates are flexible. The successful applicant will be a Ph.D. scientist responsible for management and conduct of laboratory projects under the guidance of Senior Research Professor of Neurology, Dr. Jeffrey Dage. IU School of Medicine is committed to being a welcoming campus community and we seek candidates whose research, teaching, and community engagement efforts contribute to robust learning and working environments for all students, staff, and faculty. We invite individuals who will join us in our mission to improve health equity and well-being for all throughout the state of Indiana. Indianapolis is the capital and most populous city in the State of Indiana. It is growing economically thanks to a strong corporate base anchored by the life sciences. Indiana is home to one of the nation's largest concentrations of health sciences companies. Indianapolis has a sophisticated blend of charm and culture with a wonderful balance of business and leisure. The growing residential base is supported by rich amenities and quality of life - the city possesses a variety of professional sports, arts venues, and outdoor recreation areas. Residents of this dynamic city and surrounding suburbs enjoy leading educational systems and top-ranked universities paired with a diverse population. Indianapolis International Airport is a top-ranked international airport that has been named “Best Airport in North America” by Airports Council International for many years. For additional information on life in Indy: ******************************************
$102k-146k yearly est. 60d+ ago
Global R&D Data Scientist / Chemometrician
Corbion 4.1
Research scientist job in Indiana
At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. Corbion is a global leader in sustainable ingredient solutions, driven by the power of science and innovation. With a strong commitment to sustainability, we develop and produce high-quality ingredients that help preserve food, improve health, and protect the planet. Our solutions are trusted by industries worldwide, from food and biochemicals to pharmaceuticals. At Corbion, you'll join a diverse, collaborative team where your expertise and ideas truly make a difference.
Your Role: Data Scientist
Are you passionate about data, innovation, and making a real impact? Corbion is seeking a talented Data Scientist / Chemometrician to join our team at our Office in Navi Mumbai. In this role, you will report directly to the Senior Scientist Data Science, who is based in the Netherlands, and play a key part in mining and analyzing complex data to drive operational excellence and innovation.
Key Responsibilities
* Promote Data-Driven Decisions: Foster a data-focused culture and use advanced analytics (statistics, machine learning, AI) to deliver actionable insights and measurable impact in manufacturing, but also Innovation Center, and commercial areas.
* Statistical Training & Modelling: Train colleagues on statistical methods and tools, supporting experimental design through workshops and user guides.
* Process Optimization & Digitalization: Apply technologies like chemometrics and Process Analytical Technology (PAT) for root-cause analysis and process improvements; drive digitalization to enhance efficiency and optimize resources.
* Effective Communication & Collaboration: Present complex analyses clearly to various audiences, serve as a data science contact, and align solutions with business needs through cross-functional collaboration.
* Innovation & Continuous Improvement: Pilot new AI/ML solutions, standardize coding and documentation, and integrate data science best practices to support ongoing advancements.
About You
* You hold an advanced academic degree (MSc or PhD) in Data Science, Computer Science, Chemometrics or a related STEM field.
* You are proficient in programming languages such as Python, R, or SQL, and apply them effectively in analytical workflows.
* You have practical experience with data visualization tools like Power BI, enabling clear and impactful communication of insights.
* You bring a strong analytical mindset and approach challenges with critical thinking and problem-solving skills.
* You are self-driven and capable of managing multiple projects and support requests independently and proactively.
* You excel at communicating complex technical concepts to both technical and non-technical audiences, through clear writing and compelling presentations.
* You are fluent in English and thrive in collaborative, cross-functional environments.
Why Join Corbion?
* Be part of a global company committed to sustainability and innovation.
* Work at our regional South Asia business hub in Navi Mumbai, collaborating with international experts.
* Opportunities for professional growth and development.
* Make a real impact on the future of sustainable solutions.
Ready to shape the future with Corbion? Apply now and join our Global Data Science team.
About Corbion
Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2024, Corbion generated annual sales of €1,288.1 million and had a workforce of 2,399 FTE. For more information: ***************
Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally.
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.
$81k-112k yearly est. 23h ago
Director - Clinical Research Scientist - Global and US Medical Affairs
Eli Lilly and Company 4.6
Research scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary
The Clinical ResearchScientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans.
Key Responsibilities
1. Business & Customer Support
Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
Lead data analyses and health outcomes research to address customer questions.
Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements.
Support training of sales, medical, and patient support teams.
Lead definition of Patient Journey and contribute clinical perspective to patient programs.
Participate in relevant professional and industry associations.
2. Scientific Exchange & Data Dissemination
Ensure compliance with global and local regulations governing scientific communication.
Address unsolicited scientific inquiries in alignment with medical governance standards.
Support scientific meetings, advisory boards, symposia, and other expert engagements.
Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts.
Build and maintain relationships with key opinion leaders and scientific societies.
Represent the company at medical congresses and support scientific booth activities.
Contribute to data analyses, publication development, and Clinical Trial Registry reporting.
3. Clinical Planning
Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements.
Maintain up‑to‑date understanding of clinical and competitive data.
Provide regional clinical insights to inform development plans and study protocols.
4. Clinical Research Execution
Review and approve informed consent documents to ensure accurate risk communication.
Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out.
Support investigator/site training and address study‑related medical questions.
Oversee local safety monitoring and adverse event follow‑up.
Review investigator‑initiated trial (IIT) proposals as needed.
Ensure global alignment of Phase 3b/4 and applicable early‑phase studies.
5. Regulatory Support
Contribute to development and review of local labeling and labeling changes.
Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
Participate in risk management planning with global and local teams.
6. Scientific & Professional Development
Stay informed on therapeutic area trends, market changes, and competitive landscape.
Provide scientific training to clinical study teams and act as a protocol subject‑matter expert.
Represent the organization at medical congresses and contribute to medical budget planning.
Seek opportunities for external scientific engagement.
7. Leadership & Collaboration
Set and pursue professional development goals and support growth of colleagues and direct reports.
Contribute to recruitment, diversity, and retention efforts when applicable.
Participate in committees, Six Sigma initiatives, and cross‑functional projects.
Model leadership behaviors and serve as an ambassador for patients and the company.
Basic Qualifications
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience
Additional Preferences
Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
Ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers
Product directors, managers, and associates of the brand
Clinical research staff
Statisticians
Scientific communication associates
Medical information associates
Medical liaisons
Global patient outcomes research consultants/researchscientists and health outcomes liaisons
Regulatory directors, scientists, and associates
Sales representatives
Legal counsel
Therapeutic area physicians, global brand physicians, early phase physicians, clinical researchscientists, and Regional Medical Leader, Directors-Medical.
Corporate or regional patient safety physician(s)
External Contacts
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Practicing physicians/prescribers
Regulatory agency personnel
Professional association staff and leaders
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$177k-308k yearly Auto-Apply 3d ago
Post-Doctoral Research Associate in Transportation Engineering
Western Kentucky University 4.4
Research scientist job in Bowling Green, KY
Show Job Details for Post-Doctoral Research Associate in Transportation Engineering Apply Now for Post-Doctoral Research Associate in Transportation Engineering One to two exciting post-doctoral research associate positions are available for individuals interested to pursue scholarly research in transportation engineering at Western Kentucky University (WKU), particularly in transportation safety (crash analysis). Candidates need to demonstrate prior experience and publication record in prestigious journals specialized in traffic safety as part of their resume, such as: Accident Analysis & Prevention, Transportation Research Record, Journal of Safety Research, Safety Science, ASCE: Journal of Transportation Engineering, Traffic Injury Prevention, etc. The position is secured for one year, with the possibility of extension pending satisfactory performance and funding availability. The duties include the following:
* Work on several transportation safety grants sponsored by the Kentucky Transportation Cabinet (KYTC or the Kentucky DOT), including motorcycle safety, distracted driving crashes, roundabout and Restricted Crossing U-Turn (RCUT) intersection safety, and application of artificial intelligence and machine learning techniques for analyzing the impact of weather information on traffic safety in Kentucky.
* Write scholarly papers for submission to prestigious peer-reviewed journals (e.g., Accident Analysis & Prevention, Transportation Research Record, Journal of Safety Research, Safety Science, ASCE: Journal of Transportation Engineering, Traffic Injury Prevention, etc.) and quality conference proceedings (e.g., TRB, ASCE: ICTD, etc.).
* Assist in writing external grant proposals.
* Guide undergraduate/graduate students in their research.
* Propose research ideas for the driving simulator at the Transportation Safety & Crash Avoidance Research (TSCAR) Lab/ Facility and the upcoming Center for Transportation Research (CTR) at WKU.
* Work as a team with existing post-doctoral researchers at the "Transportation Safety & Crash Avoidance Research (TSCAR) Laboratory/Facility.
The recruited individual(s) will work directly under the supervision of Dr. Kirolos Haleem. The full-time post-doctoral researcher candidate(s) will support the growth of the WKU "Transportation Safety & Crash Avoidance Research (TSCAR) Laboratory/Facility" to be the "Center for Transportation Research" (CTR) and will work with a team of researchers, including Dr. Haleem, post-doctoral researchers, and multiple undergraduate students.
Job Requirements:
* Ph.D. degree in civil (transportation) engineering, specifically in traffic safety
Additional Information:
Kentucky state law requires all public institutions of postsecondary education to conduct pre-employment criminal background checks to determine suitability for employment.
Western Kentucky University (WKU) is committed to a policy and practice of providing equal employment and educational opportunities to all individuals. In accordance with Title VI and VII of the Civil Rights Act of 1964, Title IX of the Educational Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, Revised 1992, and the Americans with Disabilities Act of 1990, no form of discrimination or harassment will be tolerated at WKU on the basis of race, color, ethnicity, national origin, creed, religion, political belief, sex, sexual orientation, gender identity/expression, marital status, age, uniformed services, veteran status, genetic information, pregnancy, childbirth or related medical conditions, or physical or mental disability in admission to career and technical education programs and/or activities, or employment practices.
Persons with disabilities, who need reasonable accommodations to participate in the application and/or selection process, should notify the office of Institutional Equity. To request an accommodation, report a complaint, or ask questions regarding WKU's Discrimination and Harassment Policy (#0.2040), please contact Ms. Ena Demir, Executive Director/Title IX Coordinator via email at ***************** or by phone at **************. Ms. Demir is also responsible for coordinating the University's response to complaints related to sex and gender harassment. Additional information regarding Title IX is accessible via WKU's **************************** website.
Information concerning educational programs offered by WKU are provided at: **************************************
For information related to job postings, please email ******************.
$38k-49k yearly est. Easy Apply 28d ago
Bioinformatician
Padmore Global Connections
Research scientist job in Indianapolis, IN
Interview Type: In Person Only
Work Arrangement: Onsite
Engagement Type: Contract
NOTE: Applications with resumes in PDF Format will be automatically rejected. Only Word format resumes will be considered.
Short Description:
Bioinformatician working in public health laboratory, research based.
Complete Description:
Purpose of Position/Summary:
Incumbent is responsible for the study, development, maintenance, and performance of cutting-edge next generation sequencing (NGS) based biological assays in the areas of bacteriology, virology, and parasitology. In addition to the wet-lab testings this position also puts an emphasizes on the bioinformatics side of NGS utilizing advanced computational methods to analyze the results obtained from NGS assays. The incumbent should have experience with developing primer/probe sets, data analysis, and bioinformatic pipeline development.
Essential Duties/Responsibilities:
Incumbent will lead bioinformatic analysis of microbial and viral NGS data to generate actionable laboratory and public health results. Representative duties include:
Research, develop, design, validate and implement novel NGS-based laboratory assays using advanced computational resources, reproducible programming techniques, and QA methods
Perform and maintain bioinformatic analysis of NGS data using developed software and workflows.
Evaluate recent literature and standards in the field and make recommendations and changes to workflows to ensure sequencing analysis procedures are aligned with current best practices in the field.
Troubleshoot NGS assays and analysis pipelines when needed to ensure the best data is being used to generate data
Strictly follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results.
Extraction of nucleic acids from specimens, isolates, and samples via a variety of manual and automated methods;
Utilize molecular techniques such as, but not limited to, PCR, sequencing, and NGS;
Evaluate, interpret, and validate laboratory results and reports findings.
Maintain quality control of the laboratory processes as well as the analysis process to ensure that data is defendable.
Maintain an inventory of laboratory supplies and order as needed to ensure testing needs are met.
Assist in preparations of epidemiological and/or statistical reports from data compiled on a daily, weekly, monthly, or annual basis.
Maintain competency in all trained areas.
Perform all related work as required.
Testing personnel responsibilities (493.1495 Standard):
The testing personnel are responsible for specimen processing, test performance and for reporting test results.
(a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individuals education, training or experience, and technical abilities.
(b) Each individual performing high complexity testing must
(1) Follow the laboratorys procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing samples are
tested in the same manner as patient specimens;
(3) Adhere to the laboratorys quality control policies, document all quality
control activities, instrument and procedural calibrations and
maintenance performed;
(4) Follow the laboratorys established policies and procedures whenever
test systems are not within the laboratorys established acceptable levels
of performance;
(5) Be capable of identifying problems that may adversely affect test
performance or reporting of test results and either must correct the
problems or immediately notify the general supervisor, technical
supervisor, clinical consultant, or director;
(6) Document all corrective actions taken when test systems deviate from
the laboratorys established performance specifications; and
(7) Except as specified in paragraph (c) of this section, if qualified under §
493.1489(b)(5), perform high complexity testing only under the onsite,
direct supervision of a general supervisor qualified under § 493.1461.
(c) Exception. For individuals qualified under § 493.1489(b)(5), who were performing
high complexity testing on or before January 19, 1993, the requirements of
paragraph (b)(7) of this section are not effective, provided that all high complexity
testing performed by the individual in the absence of a general supervisor is
reviewed within 24 hours by a general supervisor qualified under § 493.1461.
Job Requirements:
Extensive knowledge of the principles, theories and practices of molecular biology, NGS and related sub- specialties;
Specialized knowledge of bioinformatic pipelines, analysis tools, and best practices in analysis of NGS data.
Specialized knowledge of current scientific methods and testing procedures and the ability to apply them when seeking solutions to public health laboratory problems;
Specialized knowledge of troubleshooting techniques for NGS applications at the bench level as well as in analysis
Specialized knowledge of and ability to use a full range of standard technical equipment, complex scientific apparatus, and automated techniques of analysis;
Extensive knowledge of laboratory safety practices and principles;
Aware of state and federal laws, rules, regulations, and policies concerning the program area (i.e. CLIA);
Ability to meet requirements for personnel certification as a technologist pursuant to the Clinical Laboratory Improvement Act (CLIA)
Ability to effectively communicate technical information both verbally and in writing and maintain productive working relationships;
Ability to satisfactorily participate in proficiency testing programs and recognize QA problems;
Ability to compile, analyze, evaluate, and prepare laboratory reports.
Difficulty of Work:
Incumbent is engaged in scientific analyses that demand accuracy and demonstrated proficiency in applying laboratory analytical skills to select pertinent guidelines and formulated plans for problem solving. Projects involve many complex variables of great intricacy and the microbiologist is often called upon to analyze and identify unusual specimens/samples. Work requires use of analytical judgment and technical knowledge in order to draw accurate, logical conclusions. Incumbent will also be required to develop and research new testing procedures as well as the data analysis and reporting of NGS data.
Responsibility:
Incumbent works independently as an expert in the assigned area. Technical and/or detailed instruction is provided only upon request when necessitated by a procedural change and/or special project. Incumbent maintains established safety practices when working with materials that have a chemical hazard or biohazard potential. Reports are reviewed for general technical accuracy; however, tasks are performed independently. Errors in work could adversely affect the health, safety and well being of the incumbent or coworkers.
Personal Work Relationships:
Incumbent works with supervisor and with other State Department of Health staff such as Laboratory Safety Officer and/or external entities (e.g. local health departments, etc.) to devise and implement work procedures and information dissemination. Individual will have contact with employees and the public as a laboratory expert and in the explanation of laboratory procedures and recommendations when appropriate. Incumbent will be the subject matter expert on bioinformatics ascepts of NGS results generated in our laboratory or by external partners.
Physical Effort:
The required personal protective equipment can be cumbersome and awkward. Extra effort and concentration will be necessary to perform routine laboratory manipulations under these conditions.
Working Conditions:
The incumbent will be performing tests on potentially dangerous specimens. Consequently, safety standards are of primary importance. This position will be required to use all appropriate personal protective equipment in the designated laboratory area. The laboratory space and equipment can experience a dramatic increase in temperature. The incumbent will be required to work in these conditions and maintain a clear thought process during the testing.
$57k-98k yearly est. 60d+ ago
Molecular Biologist II
South East Asia 3.8
Research scientist job in Indiana
-
Business Title: Molecular Biologist II Analyst II Division: Consumer Products Services Entity: ATL Reports to: Manager FLSA: Non-Exempt Hours Worked: Typically, Monday through Friday, forty-hours per week. However, must be flexible to meet the needs of the department and complete other projects as assigned.
Position Summary:
The Molecular Biologist II is responsible for efficient delivery of data from molecular, cellular, and molecular pharmacological biochemical assays. They are highly organized, able to execute and develop protocols for various laboratory techniques and adhere to good research practice (GRP) requirements. They are an detail-oriented laboratory scientist, conducting biochemical assays among other laboratory responsibilities independently or with little guidance from client scientists and can deliver and interpret data in a timely manner. They exhibit quality and compliance in their daily work. They are champions of and promote the organization's Values and Absolutes. The Molecular Biologist will complete their regular assigned daily work while meeting the expectations outlined below.
Duties and Responsibilities:
It is everyone's responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.
• Grow, treat, and transfect mammalian cells to isolate RNA, protein for use in biochemical assays.
• Perform standard molecular/cellular techniques, such as BCA, Western blotting, ELISAs.
• Perform in-vivo rodent tissue collections and subsequent processing of tissues for use in biochemical assays.
• Monitor inventory of laboratory supplies and reagents and maintain clean, well-functioning laboratory environment.
• Identify, troubleshoot and provide suggested technical solutions to clients and management.
• Prepare written technical reports.
• Perform basic data analysis as assigned.
• Assist with training.
• Comply with clients and Bureau Veritas Consumer Products Services, Inc management systems in accordance with appropriate regulatory agencies.
• Follows the guidelines set forth by clients and the Bureau Veritas Consumer Products Services, Inc Quality Manual and Safety / Chemical Hygiene Plan.
• Adhere to the requirements of the BV-CPS Quality System.
• Other duties as defined by Manager, department needs and workload.
Skills & Proficiencies:
• Demonstrated ability to perform complex biochemical assays and deliver data in a timely and consistent manner
• Extensive experience in molecular and biochemistry techniques
• Ability to think critically about data and troubleshoot assays as needed
• Written and verbal communication skills including the ability to communicate effectively in a group setting, with colleagues and clients
• Organizational and time management skills
• Ability to perform multiple tasks
• Ability to organize and prioritize workload to meet or exceed deadlines
• Individual and Team work ethic
• Proficiency with Windows, Word & Excel
• Attention to detail
• Positive attitude, self-motivated, high level of engagement
• Champions company values including team engagement
• Ability to present both facts and recommendations effectively
• Technical problem solving and process improvement skills
Education and Experience:
• Master's or Bachelor's in Biology, Molecular Biology, Neuroscience, or closely related field.
• Minimum of one (1) year of experience with biochemical techniques including but not limited to qPCR, FLIPR kinase assays, and mammalian cell culture.
• Minimum of one (1) year of experience with data analysis.
• Experience with or willingness to learn/perform in-vivo rodent tissue collection.
An equivalent combination of education and experience may be accepted in lieu of above.
Compensation Range: $27.00 - $29.00 per hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).
$27-29 hourly 30d ago
Online Research Participant - Earn Cash for Sharing Your Views
Opinion Bureau
Research scientist job in Mishawaka, IN
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Indiana University School of Medicine is seeking a Pediatric General Surgeon within the IUSM Department of Surgery. They will join a team of 9 Surgeons covering 3 hospitals in the urban and metro areas of Indianapolis. The Division offers and supports robust residency and fellowship programs. This role will be responsible for activities in a division which encompasses general pediatric surgery and trauma. Services specific to the Riley Children's Hospital include, but are not limited to, the surgical management of general pediatric surgery conditions, surgical oncology, congenital anomalies, chest wall anomalies, gastrointestinal surgery, as well as minimally-invasive surgery. This position will include 40% research time for health science research toward pediatric surgery patient populations. Mentorship will be provided under Dr. Karl Bilimoria. Candidate's should have experience and training in health sciences research as this is an expectation of the position. This is a full-time opportunity. Salary and academic rank will be commensurate with experience. Department of Surgery - The IUSM Department of Surgery is committed to the education and development of excellent surgical clinicians, incorporating the skills, knowledge, and competencies essential for providing a high standard of care to residents across the state of Indiana and beyond. Faculty educators in the Department of Surgery strive to advance surgical scientists and their research and aim to instill the leadership qualities that will empower graduates to excel in all practice settings. Indiana University School of Medicine - IUSM is committed to being a welcoming campus community and we seek candidates whose research, teaching, and community engagement efforts contribute to robust learning and working environments for all students, staff, and faculty. We invite individuals who will join us in our mission to improve health equity and well-being for all throughout the state of Indiana. IU Health - IU Health is Indiana's most comprehensive healthcare system (ranked No. 1 in the state by U.S. News & World Report). Our unique partnership with the Indiana University School of Medicine, one of the nation's leading medical schools, provides physicians opportunities in breakthrough research and high-quality patient care. Based in Indianapolis, Indiana, with dozens of facilities statewide, IU Health is a regional leader in providing the right healthcare when and where it is needed. Indianapolis - Indianapolis is the capital and most populous city in the State of Indiana. It is growing economically thanks to a strong corporate base anchored by the life sciences. Indiana is home to one of the largest concentrations of health sciences companies in the nation. Indianapolis has a sophisticated blend of charm and culture with a wonderful balance of business and leisure. The growing residential base is supported by rich amenities and quality of life - the city possesses a variety of professional sports, arts venues, and outdoor recreation areas. Residents of this dynamic city, and surrounding suburbs, enjoy leading educational systems and top-ranked universities, paired with a diverse population. Indianapolis International Airport is a top-ranked international airport, being named “Best Airport in North America” by Airports Council International for many years. For additional information on life in Indy: ******************************************
$102k-146k yearly est. 60d+ ago
Clinical Research Scientist - Breast Cancer Franchise
Eli Lilly and Company 4.6
Research scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Overview:
The Development Clinical ResearchScientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
Primary Responsibilities
Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
Demonstrate compliance with procedures and be accountable for compliance of team members.
Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
Collaborate with Global Patient Safety on risk management planning.
Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
Partake in data analysis, scientific dissemination, and preparation of final study reports.
Analyze and contextualize clinical data to support decision-making and portfolio strategy.
Contribute to strategy and innovation through cross-functional working groups.
Support planning and execution of symposia, advisory boards, and other external engagements.
Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Scientific & Technical Expertise and Development
Stay current with medical literature and scientific developments in breast oncology.
Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
Leadership & Professional Development
Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
Basic qualifications:
PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
3+ years of clinical researchscientist experience/clinical trial experience
Leadership experience
Additional Information/Preferences:
Direct Line Leadership experience Breast cancer disease state knowledge/experience
An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
Strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$177k-308k yearly Auto-Apply 60d+ ago
Specialist, STEM Scholarships and External Research
Western Kentucky University 4.4
Research scientist job in Bowling Green, KY
Show Job Details for Specialist, STEM Scholarships and External Research Apply Now for Specialist, STEM Scholarships and External Research Established in 2008, OSD promotes scholar development by helping students in all majors and degree programs pursue opportunities that fund "academic extras" beyond what tuition covers. OSD identifies opportunities for students to engage in their academic field beyond the classroom, then helping students develop strong proposals, secure recommendation letters and references, revise numerous drafts of application materials, and prepare for interviews. OSD fosters reflective dialogue with and among students to deepen students' understanding of their purpose, goals, and pathways to professional growth.
* Recruit and advise students applying for STEM-related (NSF REU and GRFP, NIH SIP, DoD SMART, Goldwater, etc.) and other nationally competitive opportunities (Gilman Scholarship, Fulbright U.S. Student Program, etc.), supporting student applications from first drafts to final submission, helping them identify their goals and their motivations and communicate those ideas in essay format.
* Liaise with other university units, academic departments and centers in the Ogden College of Science and Engineering, and STEM faculty to publicize scholarship competitions, cultivate applicants through outreach programming, and develop pipelines to identify, recruit, and support the scholar development of high potential STEM students throughout their academic careers at WKU.
* Develop informational literature for STEM students, faculty, and staff to promote the mission of the office.
* Manage campus evaluation committees consisting of faculty and staff in Ogden College departments.
* Implement assessment processes to collect, analyze, and act on data, and maintain information systems for reporting to various audiences.
Job Requirements:
* Bachelor's degree from an accredited institution
* Willingness to work some evenings and weekends and travel occasionally
* Demonstrated proficiency in Microsoft Office (especially Word, Excel, and Outlook) and ability to learn web-hosted applications and systems that support the work of the office
Additional Information:
Salary Range: $38,000 - $45,000
Kentucky state law requires all public institutions of postsecondary education to conduct pre-employment criminal background checks to determine suitability for employment.
Western Kentucky University (WKU) is committed to a policy and practice of providing equal employment and educational opportunities to all individuals. In accordance with Title VI and VII of the Civil Rights Act of 1964, Title IX of the Educational Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, Revised 1992, and the Americans with Disabilities Act of 1990, no form of discrimination or harassment will be tolerated at WKU on the basis of race, color, ethnicity, national origin, creed, religion, political belief, sex, sexual orientation, gender identity/expression, marital status, age, uniformed services, veteran status, genetic information, pregnancy, childbirth or related medical conditions, or physical or mental disability in admission to career and technical education programs and/or activities, or employment practices.
Persons with disabilities, who need reasonable accommodations to participate in the application and/or selection process, should notify the office of Institutional Equity. To request an accommodation, report a complaint, or ask questions regarding WKU's Discrimination and Harassment Policy (#0.2040), please contact Ms. Ena Demir, Executive Director/Title IX Coordinator via email at ***************** or by phone at **************. Ms. Demir is also responsible for coordinating the University's response to complaints related to sex and gender harassment. Additional information regarding Title IX is accessible via WKU's **************************** website.
Information concerning educational programs offered by WKU are provided at: **************************************
For information related to job postings, please email ******************.
$38k-45k yearly Easy Apply 60d+ ago
Online Research Participant - Earn Cash for Sharing Your Views
Opinion Bureau
Research scientist job in Portage, IN
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$61k-112k yearly est. 1d ago
Director - Clinical Research Scientist
Eli Lilly and Company 4.6
Research scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Development Clinical ResearchScientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues.
Roles and Responsibilities of the Position:
Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical ResearchScientist will apply scientific and clinical training and expertise to described roles.
Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Reporting of adverse events as mandated by corporate patient safety.
Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies.
Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed.
Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions.
Minimum Requirements:
An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty).
1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology.
Additional Preferences:
Breast cancer disease area knowledge.
Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team.
Proven track record to bring out the best in others on a cross-functional international team. Leading by influence.
Proven track record to interact externally and internally to support a global scientific and business strategy.
Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel.
Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
Strong communication, both written and oral.
Ability to multi-task and shift priorities rapidly to meet target dates.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $259,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-259.6k yearly Auto-Apply 3d ago
Online Research Participant - Earn Cash for Sharing Your Views
Opinion Bureau
Research scientist job in Georgetown, KY
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$31k-58k yearly est. 1d ago
Clinical Research Scientist - Breast Cancer Franchise
Eli Lilly and Company 4.6
Research scientist job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Overview:
The Development Clinical ResearchScientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
Primary Responsibilities
Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
Demonstrate compliance with procedures and be accountable for compliance of team members.
Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
Collaborate with Global Patient Safety on risk management planning.
Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
Partake in data analysis, scientific dissemination, and preparation of final study reports.
Analyze and contextualize clinical data to support decision-making and portfolio strategy.
Contribute to strategy and innovation through cross-functional working groups.
Support planning and execution of symposia, advisory boards, and other external engagements.
Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Scientific & Technical Expertise and Development
Stay current with medical literature and scientific developments in breast oncology.
Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
Leadership & Professional Development
Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
Basic qualifications:
PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
3+ years of clinical researchscientist experience/clinical trial experience
Leadership experience
Additional Information/Preferences:
Direct Line Leadership experience Breast cancer disease state knowledge/experience
An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
Strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$177k-308k yearly Auto-Apply 34d ago
Online Research Participant - Earn Cash for Sharing Your Views
Opinion Bureau
Research scientist job in Shelbyville, TN
Take quick online surveys and earn rewards for sharing your thoughts. Join today - it's free and easy!
$40k-76k yearly est. 1d ago
Director - Clinical Research Scientist - Global and US Medical Affairs
Eli Lilly and Company 4.6
Research scientist job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary
The Clinical ResearchScientist (CRS) within the Business Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are effectively integrated into local business activities and global development plans.
Key Responsibilities
1. Business & Customer Support
Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
Lead data analyses and health outcomes research to address customer questions.
Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
Provide medical expertise for payer partnerships, promotional material review, and business‑to‑business/government engagements.
Support training of sales, medical, and patient support teams.
Lead definition of Patient Journey and contribute clinical perspective to patient programs.
Participate in relevant professional and industry associations.
2. Scientific Exchange & Data Dissemination
Ensure compliance with global and local regulations governing scientific communication.
Address unsolicited scientific inquiries in alignment with medical governance standards.
Support scientific meetings, advisory boards, symposia, and other expert engagements.
Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts.
Build and maintain relationships with key opinion leaders and scientific societies.
Represent the company at medical congresses and support scientific booth activities.
Contribute to data analyses, publication development, and Clinical Trial Registry reporting.
3. Clinical Planning
Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
Communicate local research needs to ensure Phase I-IV programs reflect market and customer requirements.
Maintain up‑to‑date understanding of clinical and competitive data.
Provide regional clinical insights to inform development plans and study protocols.
4. Clinical Research Execution
Review and approve informed consent documents to ensure accurate risk communication.
Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close‑out.
Support investigator/site training and address study‑related medical questions.
Oversee local safety monitoring and adverse event follow‑up.
Review investigator‑initiated trial (IIT) proposals as needed.
Ensure global alignment of Phase 3b/4 and applicable early‑phase studies.
5. Regulatory Support
Contribute to development and review of local labeling and labeling changes.
Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
Participate in risk management planning with global and local teams.
6. Scientific & Professional Development
Stay informed on therapeutic area trends, market changes, and competitive landscape.
Provide scientific training to clinical study teams and act as a protocol subject‑matter expert.
Represent the organization at medical congresses and contribute to medical budget planning.
Seek opportunities for external scientific engagement.
7. Leadership & Collaboration
Set and pursue professional development goals and support growth of colleagues and direct reports.
Contribute to recruitment, diversity, and retention efforts when applicable.
Participate in committees, Six Sigma initiatives, and cross‑functional projects.
Model leadership behaviors and serve as an ambassador for patients and the company.
Basic Qualifications
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 10 years experience and at least 1 year of gastroenterology pharmaceutical experience
Additional Preferences
Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
Ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrate strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrate ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers
Product directors, managers, and associates of the brand
Clinical research staff
Statisticians
Scientific communication associates
Medical information associates
Medical liaisons
Global patient outcomes research consultants/researchscientists and health outcomes liaisons
Regulatory directors, scientists, and associates
Sales representatives
Legal counsel
Therapeutic area physicians, global brand physicians, early phase physicians, clinical researchscientists, and Regional Medical Leader, Directors-Medical.
Corporate or regional patient safety physician(s)
External Contacts
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Practicing physicians/prescribers
Regulatory agency personnel
Professional association staff and leaders
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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How much does a research scientist earn in Bowling Green, KY?
The average research scientist in Bowling Green, KY earns between $41,000 and $90,000 annually. This compares to the national average research scientist range of $58,000 to $137,000.
Average research scientist salary in Bowling Green, KY