Analytical Scientist jobs at Ricerca Biosciences

We are looking to fill a **Scientist 3 - Analytical Chemist** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Multi-Family Pre-Clinical Development - Medtech Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: We are searching for the best talent for a Principal Scientist, Nonclinical Surgery located in Cincinnati, OH. Purpose: Functioning as a primary surgeon, with a primary focus on cardiovascular procedures, to provide surgical expertise and technical leadership during research, development, and evaluation of surgical devices using animate, inanimate, and cadaveric models. Performing surgical research & testing which support development of products or procedures in standard and minimally invasive surgery (open, laparoscopic, and robotic). Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will: Conducting and / or directing surgical investigations for product development and preclinical evidence generation. Use scientific and surgical expertise to evaluate functionality, efficacy, and safety of medical devices during acquisition, licensure, discovery, development, and product change evaluations. Provide biomedical expertise by making unbiased recommendations to ETHICON teams regarding new technologies and interaction of device concepts on living tissue. Provide technical direction and execution within Preclinical Research for surgical investigation and development of medical devices. Collaborating with Preclinical Research team to apply clinically relevant models for product evaluation, while meeting preclinical study design, execution, and timeline requirements. Support the Preclinical Research team with the development of animal models. Responsible for communicating business related issues or opportunities to next management level For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Know & follow ETHICON policies & procedures related to work activities performed in area of responsibility. Utilize interpersonal skills and collaboration to enhance team processes and drive surgical efficiency/quality within Preclinical Research, ETHICON, and J&J. Function as key Preclinical Research team member by energetically supporting the goals of the department, ETHICON, and J&J by actively participating in and collaborating with the external scientific community. Performs other duties assigned as needed Education: A minimum of a Doctorate degree is highly preferred (DVM/VMD from an (AVMA) American Veterinary Medical Association accredited program; MD is also acceptable with significant preclinical experience) Surgical residency training and board certification (DACVS) is preferred. Certification as a Surgical Research Specialist (SRS) through the Academy of Surgical Research may also be considered based on experience level. Demonstrated knowledge of surgical principles and theory is required, with specific training in cardiovascular procedures also required. Demonstrated knowledge and experience in performing fluoroscopic angiography in large animals is required Experience in executing preclinical and/or clinical studies, including GLP, with external contract research organizations is preferred. Ability to work collaboratively with the preclinical research team is required. Familiarity with Medical Device Product Development is preferred. Knowledge of preclinical regulatory requirements for FDA and notified bodies outside the US is preferred. Required Skills & Experience: Extensive knowledge of cardiovascular surgery as well as interventional procedures. Deep knowledge of animal and human anatomy and physiology, as well as biological systems. Demonstrated analytical problem-solving and decision-making skills. Demonstrated surgical expertise during research, development, & evaluation by utilizing animate, inanimate and cadaveric models. Ability to work as a technical leader, team member, and role model for preclinical staff. Excellent communication skills - written/oral/listening. Working with minimal supervision. Ability to clearly document and communicate plans and results. Possess the motivation and work ethic to successfully complete studies/surgical procedures on time and with high quality. Able to manage multiple tasks and responsibilities. Serve as a preclinical subject matter expert on technical/surgical evaluation concerning device performance. Able to bring new scientific principles / innovative technical solutions to projects / studies. Robust surgical technique & mastery of open and laparoscopic procedures spanning multiple animal models. Robotic surgical experience is desired, but not required. Knowledge of regulations regarding medical device development and the utilization of live animals in preclinical research. Other: This position is based in Cincinnati, OH, and requires up to 25% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: MilliporeSigma in Miamisburg, OH is hiring an Associate Production Scientist. In this role, you will manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Responsibilities: Safely perform operations to meet quality expectations Ensure quality throughout the process Complete the volume of work required to achieve group/departmental goals and meet deadlines Participate as needed in quality audits In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles Identify opportunities for process improvement Physical Attributes: Wearing appropriate protective gear, (hard hats, glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protection equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors or airborne particles Working in outdoor weather conditions while moving material, filling material and waste handling Lifting and/or moving to 50 pounds unassisted and ability to push and pull heavy materials to complete assignment. Lifting more poundage with assistance. Utilize close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus Who You Are: Minimum Qualifications: Bachelor's degree in Chemistry, Biochemistry, Biology or other Science discipline Preferred Qualifications: Bachelor's degree in Chemistry Experience with safe chemical handling methods Excellent communication skills both oral and written Computer skills Mechanical skills Troubleshooting skills Interpersonal skills Organizational skills Knowledge of ISO Quality standards Pay Range for this position: $25.00 - $44.00/hour The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Carry out QC lab analysis of raw materials, in process samples, final products, and project samples so that results are accurately determined in a timely manner, properly communicated to customers, and performed in accordance with the established Quality Systems based on ISO 9001, FSSC 22000/ISO 22002, and all applicable cGXP. This ensures that the manufacturing operation is well supported, and outside customers are promptly served with the correct product, quality, and information. As needed develop and validate analytical methods. Review data, processing records and or all other quality records for accuracy prior to release. Assist with Regulatory requests as it pertains to Quality Assurance. ESSENTIAL DUTIES AND RESPONSIBILITIES Key responsibilities include, but are not limited to the following: Carry out all work to the appropriate Quality Standards, ISO 9001, FSSC 22000/ISO 22002, cGXPs, and API, as appropriate in each laboratory. Flag any issues as they arise. Responsible for daily calibrations of all lab equipment and maintenance of records to the appropriate Quality Standards to ensure equipment is always ready for use. Work independently, as well as in a team, so that work is smoothly and efficiently handled, shift hand-over is completed with a full understanding of ongoing issues, support production operators in their in-process testing, with clear and current communication with the lab manager/supervisor of issues and how they are being handled. Recognize, investigate, and troubleshoot questionable results and equipment problems so that resolution of the matter is obtained in a timely manner, and the proper people are kept informed or asked for guidance. Analyze incoming raw materials, in process samples, finished goods, and project samples per the established SOPs using various instrumentation and techniques in the QC and API laboratories. Fully functional in API testing and API data review. Manages OOS investigations and ensures timely closure and resolution. Responsible in ensuring any CAPAs implemented were effective and monitored. Drive the implementation of new testing methods and/or method improvments. Primary trainer in laboratory testing and tasks. Follows all Company policies, procedures, and instructions using cGMP so that work is properly and safely done, the quality system is maintained, and good housekeeping is carried out. Communicates fully with internal and external customers so that their requirements and results are fully understood, and any interpretation of the information is properly supplied. Attend morning meetings with production to discuss testing status. Review and approve the daily logs reported by the QC lab. Provide technical and hands on leadership to resolve analytical issues, maintain all instruments, and help communicate data. Ensure all instruments are functional and in good working order and meeting compliance requirements. Serve as a technical resource for customer complaints and requests. Input, update, and maintain specifications across the databases and systems and work with the Technical Team. Lead special projects through completion including, but not limited to, validation work. Oversee quarterly testing and data monitoring. Evaluate current instrumentation and their performance and make recommendations on potential new technologies and/or replacements. Note: The duties listed above are not all inclusive and may be subject to periodic updating or revision. The Ideal Candidate Desired Background Bachelor's degree in chemistry, or related field of study and a minimum of 5 years of lab experience. Knowledge, Skills & Talents More specifically, we would seek the following attributes and competencies for the position: Must be able to apply good safety practice, good laboratory practice - GLP, ISO 9001. Experience in cGMP, GDP and operate to the quality regime, i.e. FSSC 22000/ISO 22002 is strongly preferred. Has demonstrated experience and competence with all instrumental analysis and wet chemistry techniques such as GC, GC MS, HPLC, TLC, Liquid Chromatography, automated titrations, physical property testing, color measurement, and spectroscopic techniques; as well as be able to teach the techniques, demonstrate good lab practice, do basic troubleshooting, and maintain good records including lab books. A good sense of smell is required for organoleptic testing. Computer skills are required as the chemists must be able to use databases, spreadsheets, word processing software, LIMS, and computer-controlled instruments. Must have excellent written and verbal communication skills. Strong organizational skills, decision-making, and record keeping skills are also required. The ability to work in a team environment as well as independently with minimal supervision is necessary with an aptness to provide adequate communication. This individual will be customer facing and may be required to communicate with customers and team members. Must have flexibility to work any other shifts and be able to work overtime as required. Is a strong and reliable trainer. Highly skilled in analytical instrument operation, troubleshooting, and maintenance. Ability to assist in research and development of methodology for new product analysis implementation. Pay and Benefits The pay rate for this position starts at $28.00/hr. Actual pay will be determined based on education, certifications, experience, qualifications, skills and geographic location. This position is eligible to participate in a short-term incentive program. Vantage offers a comprehensive benefits package to eligible employees, including: Medical, HSA, dental, vision FSA (limited purpose, dependent care, and commuter/parking) Life and AD&D insurance Accident, hospital indemnity and critical illness insurance Short- and long-term disability EAP, identity theft protection Paid time off, Parental Leave 401(k) with company match Equal Employment Opportunity Vantage is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other protected category. About Vantage Vantage provides natural solutions to our customers' technical performance and marketing needs through a unique combination of chemistry, application expertise and service. Underpinned by our broad portfolio of formulations, ingredients and actives that are built on a backbone of sustainable oils, fats and their derivatives, Vantage targets selected markets and applications including personal care, food, surface treatment, agriculture, pharma, and consumer and industrial performance. Vantage is headquartered in Deerfield, IL., operates in 11 countries worldwide and employs more than 1,000 talented professionals focused on delivering exceptional customer experiences with every interaction. We are a dynamic people-centered organization where you'll be part of a collaborative global team. Embracing our cultural diversity, we learn from each other to constantly improve, adapt and iterate. We value the voices and talents of our colleagues, empowering them to drive their unique ideas to completion. We're convinced that exceptionally motivated employees produce outstanding results and we celebrate them by fostering a culture of recognition, development, learning, excellence and shared achievement. Most importantly, we know you're going to like it here. For more information visit: vantagegrp.com or LinkedIn/vantage.

Job Description Title: Scientist/Senior Scientist Reports To: Study Director Manager Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary We are currently looking for a scientist/senior scientist to be located on-site at our Concord, OH toxicology facility to develop in vitro toxicology assays and new approach methodologies (NAMs). Scientists at Frontage Laboratories serve as technical experts and consultants in in vitro toxicology and related fields, working in a collaborative environment on projects throughout the discovery and development continuum and have a passion for science and quality. The ideal candidate will have knowledge of New Approach Methodologies (NAMs) to replace or reduce the use of animals in drug development and to refine the use of animals to achieve better results.in vitro toxicology. Experience in regulatory toxicology and familiarity with Good Laboratory Practices (GLPs) and drug development is preferred but not required. Roles & Responsibilities Knowledge and Experience: Full knowledge of New Approach Methodologies (NAMs) for use in toxicological research and implement NAMs in drug development processes. Method Development & Validation: Hands-on experience in developing, optimizing, and validating novel in vitro toxicology platforms (i.e., cell cultures, organoids, or high-throughput systems). Laboratory Execution: Performing experiments using modern instruments including but not limited to flow cytometry and plate readers, etc. Data Interpretation & Reporting: Interpreting and reporting experimental data; familiarity with computational modeling and statistical analysis. Scientific and Regulatory Compliance: Ensuring all experimental activities adhere to guidelines and supporting regulatory submissions by providing data that can waive or reduce the need for animal testing. Collaboration and Communication: Working closely with collaborators; Demonstrating scientific leadership through participation in professional organizations, presentations, and publications. Additional Responsibilities: Performing additional duties and tasks assigned by the Management. Qualifications/Requirements: Master or PhD in cell biological sciences or related fields. Preferably (3+ years) experience of in vitro toxicology in a CRO, pharmaceutical, or biotechnology setting; however, qualified candidates with other relevant experience are encouraged to apply. Proficiency in techniques such as cell culture, molecular biology, and biomarker development. Knowledge of NAMs and AI tools in drug discovery and development. Strong, effective written and oral communication skills, including the ability to organize and clearly present complex data and concepts. Ability to work in a fast-paced environment, manage multiple projects, demonstrate consistent productivity, and meet project timelines. Ability to work independently and collaboratively. Salary and Benefits Frontage Laboratories offer a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, short and long‑term disability insurance, life insurance etc. Concord, Ohio is a township about 30 miles east of Cleveland. The housing is more affordable than many areas close to major cities and is nestled in a rural setting, yet with good restaurants, shopping, and schools within the township. We consider the lifestyle and proximity to attractions in Cleveland to be a hidden benefit of living and working in Concord. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Analytical Chemistry Scientist to join our Bioanalytical Lab team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Develop and validate LC-MS/MS, GC-MS, ICP-MS, HPLC methods for small molecule drugs or drug metabolites and biomarkers; * Draft study protocols/plans, acquisition methods, and study reports; * Supervise all phases of bioassays to support pre-clinical and clinical pharmacokinetics, PD Biomarkers; * Supervise technicians for performing method development, validation, and sample analysis; * Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence etc. Qualifications * PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field; * Previous experience with small molecule drug and drug metabolites analysis; * Strong project management, compliance, communication, and people skills; * Experience with various extraction procedures, such as LLE, SPE, SLE+, immune-capture hybrid extraction, etc.; * Experience with LC-MS/MS, GC-MS, ICP-MS, HPLC, etc.; * Direct working experience in Good Laboratory Practices is preferred. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Nature and Scope As part of a team of Analytical Chemists, this position is responsible for performing the analytical activities necessary to support finished product and raw material groups. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs. Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products. Assist in the identification of synthetic impurities and potential degradation products utilizing various chromatographic and spectroscopic techniques. Perform analytical analysis using HPLC, GC, UV/VIS and FTIR. Create and maintain accurate lab record documentation. Perform routine maintenance and calibration of laboratory instrumentation. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. B.S. in Chemistry, Pharmaceutical Science or related field required. Knowledge and familiarity of equipment including HPLC/GC instrumentation, Atomic Absorption, UV/Vis and FT/IR Spectrophotometers. Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Title: Scientist, Genetic Toxicology Reports To: Study Director/ Manager Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: We are seeking a detail-oriented and highly collaborative person for a Scientist role to support client‑driven projects using Genetic Toxicology techniques. The successful candidate will work hands‑on in the lab to develop and validate new genetic toxicology assays to meet growing business needs, effectively communicate with internal teams and clients. Responsibilities: Validate unique genetic toxicology assays, trouble shooting for the existing assays, if and when needed Perform experimental phases of GLP and non-GLP studies. Act as Study Director, if and when needed, to conduct GLP and non-GLP studies. Simultaneously handle new assay development and conducting client studies. Ability to work on multiple projects at the same time. Coordinate with department and site management. Write reports for the validation studies and study reports for the assigned client studies while working as Study Director by maintaining the proper level of regulatory compliance and addressing QA audit findings. Maintain tools, computer programs, and SOPs required for studies. Research literature and external sources and identify new techniques and procedures that strengthen Frontage's capabilities. Help with training and/or mentoring of junior scientific staff. Ensure that GLP regulations and SOPs are followed in all service activities. Set-up, utilize, and maintain complex instrumentation Follow safety precautions. Education and Requirements: Understanding of genetic toxicology assays and OECD and ICH guidelines. Experience with flow cytometry. Proven ability to successfully work in a team environment. Excellent oral and written communication skills. PhD with 3 years or MS with 5 years of hand-on working experience in GeneTox labs. Previous working experience in GLP setup is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Nature and Scope Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Conduct laboratory experiments with minimal supervision to support formulation and process development of injectables Execute laboratory studies for characterization, stability studies per ICH guidelines, component selection and scale-up activities Execute and support the formulation team on experiments to support the selection of process parameters and development of manufacturing process. Prepare formulations to support analytical method development. Draft protocols/reports on the formulation development experiments and deliver data presentations. Assist in the general operation of the R & D formulation laboratory including maintenance of Standard Operating Procedures (SOP's) and equipment validation or maintenance. Maintain clean and safe work environment in the laboratory. Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health & safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. B.S. in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required. 2-3 years, or for M.S. 0-2 year, of experience in drug product development required. Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl Fisher titrator is a plus. Excellent organizational, interpersonal and communication skills required. Proficiency in Microsoft Office Word and Excel is required. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Position requires working in the laboratory as well as sitting. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

We are looking to fill a **Scientist II or III - Metrology Specialist** position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. **Job Summary** We are seeking a **Support Scientist I (Bioanalytical Chemistry)** for our Safety Assessment Group site located in **Ashland, Ohio** . **Basic Summary:** Entry level support scientist developing skills to understand assigned department study designs. Limited or basic knowledge of data collection systems. Introduction to protocol development, regulatory compliance and internal systems utilized in the conduct of a study. Excellent verbal and written communication skills. Train to become proficient in direct communication with clients. Develop training in quantitative data analysis review. **Essential Duties and Responsibilities:** _(The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:_ + Create/customize planning tools to facilitate prioritization of daily activities. + Maintain department, study, and inventory trackers in support of Project Scientist. + Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits. + With guidance, write initial protocol drafts. Upon study director approval, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process. + With guidance, facilitate signature/approval process for protocol, amendments, and other required forms. + With guidance, tabulate study data and schedule data review meetings. + Assist in the creation/generate special tables for sponsors as needed. + With guidance, assemble report (text and data tables) for senior scientific review, QA audits, and final report compilation. + Ensure that all study books are corrected appropriately, and that documentation is GLP compliant prior to submission to QA. + Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOP). Assist in drafting new or study specific SOPs. + Efficiently perform, review, and document all study data, procedures, materials, and results in compliance with applicable regulatory standards, SOPs, and methods/protocols. + Effectively complete administrative tasks such as filing and placing orders as needed. + Develop effective communication skills through informal discussions with peers, supervisor, team and Sponsor/SDs. + Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas. + Perform all other related duties as assigned. **The pay range for this position is $22-24 USD per hour. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location. *THIS IS A HYBRID ROLE*** **Job Qualifications** _(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:_ + Education: High School diploma or General Education Degree (G.E.D.) preferred. Associate's degree (A.A./A.S.) or equivalent from two-year college recommended. Bachelor's degree (B.A./B.S.) or equivalent in related discipline strongly recommended. + Experience: Zero to two years related experience in biology, chemistry/pharmacy, or similar lab environment. GLP experience preferred. + An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. + Certification/Licensure: None. + Other: This position requires analytical thinking skills and a good understanding of scientific processes. Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. Knowledge of GLP regulations and understanding of routine study design and protocols. **Comments:** + This position requires overtime, weekend, holiday, and/or after hours shift coverage, as needed. **About Safety Assessment** Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 229631

Nature and Scope As part of a team of Analytical Chemists, this position is responsible for performing the analytical activities necessary to support finished product and raw material groups. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs. * Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products. * Assist in the identification of synthetic impurities and potential degradation products utilizing various chromatographic and spectroscopic techniques. * Perform analytical analysis using HPLC, GC, UV/VIS and FTIR. * Create and maintain accurate lab record documentation. * Perform routine maintenance and calibration of laboratory instrumentation. * Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * B.S. in Chemistry, Pharmaceutical Science or related field required. * Knowledge and familiarity of equipment including HPLC/GC instrumentation, Atomic Absorption, UV/Vis and FT/IR Spectrophotometers. * Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. * Employee must be able to occasionally lift and/or move up to 25 pounds. * While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Title: Scientist/Senior Scientist Reports To: Study Director Manager Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary We are currently looking for a scientist/senior scientist to be located on-site at our Concord, OH toxicology facility to develop in vitro toxicology assays and new approach methodologies (NAMs). Scientists at Frontage Laboratories serve as technical experts and consultants in in vitro toxicology and related fields, working in a collaborative environment on projects throughout the discovery and development continuum and have a passion for science and quality. The ideal candidate will have knowledge of New Approach Methodologies (NAMs) to replace or reduce the use of animals in drug development and to refine the use of animals to achieve better results.in vitro toxicology. Experience in regulatory toxicology and familiarity with Good Laboratory Practices (GLPs) and drug development is preferred but not required. Roles & Responsibilities Knowledge and Experience: Full knowledge of New Approach Methodologies (NAMs) for use in toxicological research and implement NAMs in drug development processes. Method Development & Validation: Hands-on experience in developing, optimizing, and validating novel in vitro toxicology platforms (i.e., cell cultures, organoids, or high-throughput systems). Laboratory Execution: Performing experiments using modern instruments including but not limited to flow cytometry and plate readers, etc. Data Interpretation & Reporting: Interpreting and reporting experimental data; familiarity with computational modeling and statistical analysis. Scientific and Regulatory Compliance: Ensuring all experimental activities adhere to guidelines and supporting regulatory submissions by providing data that can waive or reduce the need for animal testing. Collaboration and Communication: Working closely with collaborators; Demonstrating scientific leadership through participation in professional organizations, presentations, and publications. Additional Responsibilities: Performing additional duties and tasks assigned by the Management. Qualifications/Requirements: Master or PhD in cell biological sciences or related fields. Preferably (3+ years) experience of in vitro toxicology in a CRO, pharmaceutical, or biotechnology setting; however, qualified candidates with other relevant experience are encouraged to apply. Proficiency in techniques such as cell culture, molecular biology, and biomarker development. Knowledge of NAMs and AI tools in drug discovery and development. Strong, effective written and oral communication skills, including the ability to organize and clearly present complex data and concepts. Ability to work in a fast-paced environment, manage multiple projects, demonstrate consistent productivity, and meet project timelines. Ability to work independently and collaboratively. Salary and Benefits Frontage Laboratories offer a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, short and long‑term disability insurance, life insurance etc. Concord, Ohio is a township about 30 miles east of Cleveland. The housing is more affordable than many areas close to major cities and is nestled in a rural setting, yet with good restaurants, shopping, and schools within the township. We consider the lifestyle and proximity to attractions in Cleveland to be a hidden benefit of living and working in Concord. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Do you have a passion for Artificial Intelligence (AI) and are looking to make a difference in how the latest clinical trials progress into the market? Do you have a background in data science and/or computer science with experience working with AI tools for interactive AI applications across various IT systems? If so, we have an exciting opportunity for you to help take the reins of a groundbreaking project at Medpace. We are currently seeking a professional with direct experience interacting with artificial intelligence (AI) tools such as NLP, LLM, IA etc. This professional will be expected to lead the programming and fine-tuning of various AI tools and help IT teams to implement them into new applications. This professional will work collaboratively across the organization with multiple teams to help design the roadmap for how AI can improve efficiency of company processes and provide insights and assistance to users. Applicants should have sufficient technical skills to help lead these types of AI projects independently and to train technical teams for support. Responsibilities * Lead the ideation, research, PoC programming and then support programming and fine-tuning of various AI tools with the IT team to implement them into new applications; * Lead the identification and development of AI tools such as NLP, LLM, and IA; * Design, develop, and implement artificial intelligence (AI) models and algorithms for various applications; * Work on a broad set of tasks encompassing various forms of machine intelligence (e.g., machine learning, algorithms, neural networks, computer vision, robotics) to develop AI models for specific applications; * Train AI models using various algorithms and techniques, optimizing for accuracy, efficiency, and interpretability; * Deploy AI solutions into production environments, ensuring scalability, reliability, and integration with existing systems; * Continuously improve models based on feedback and performance metrics; * Lead AI team activities in educating Medpace AI users in the best development, training and deployment of AI tools including various forms of machine intelligence; and * Participate in educating, training and development of more junior team members. Qualifications * PhD in Artificial Intelligence, Computer or Data Science, or related field; * Preferably several years of experience working with different AI capabilities and showcasing your passion both at work and outside work in the development of highly complex AI models (NLP, LLMs, Deep learning etc); * Technical proficiency in programming languages and frameworks commonly used in NLP and AI (e.g., Python, TensorFlow, PyTorch); * Excellent communication skills to collaborate effectively with cross-functional teams; * Demonstrated ability to lead projects independently and mentor technical teams; * A passion for staying up-to-date with the latest advancements in NLP and AI technologies; and * Analytical thinker with great attention to detail. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary We are seeking a Support Scientist I (Bioanalytical Chemistry) for our Safety Assessment Group site located in Ashland, Ohio. Basic Summary: Entry level support scientist developing skills to understand assigned department study designs. Limited or basic knowledge of data collection systems. Introduction to protocol development, regulatory compliance and internal systems utilized in the conduct of a study. Excellent verbal and written communication skills. Train to become proficient in direct communication with clients. Develop training in quantitative data analysis review. Essential Duties and Responsibilities: (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: Create/customize planning tools to facilitate prioritization of daily activities. Maintain department, study, and inventory trackers in support of Project Scientist. Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits. With guidance, write initial protocol drafts. Upon study director approval, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process. With guidance, facilitate signature/approval process for protocol, amendments, and other required forms. With guidance, tabulate study data and schedule data review meetings. Assist in the creation/generate special tables for sponsors as needed. With guidance, assemble report (text and data tables) for senior scientific review, QA audits, and final report compilation. Ensure that all study books are corrected appropriately, and that documentation is GLP compliant prior to submission to QA. Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOP). Assist in drafting new or study specific SOPs. Efficiently perform, review, and document all study data, procedures, materials, and results in compliance with applicable regulatory standards, SOPs, and methods/protocols. Effectively complete administrative tasks such as filing and placing orders as needed. Develop effective communication skills through informal discussions with peers, supervisor, team and Sponsor/SDs. Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas. Perform all other related duties as assigned. The pay range for this position is $22-24 USD per hour. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location. *THIS IS A HYBRID ROLE* Job Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: Education: High School diploma or General Education Degree (G.E.D.) preferred. Associate's degree (A.A./A.S.) or equivalent from two-year college recommended. Bachelor's degree (B.A./B.S.) or equivalent in related discipline strongly recommended. Experience: Zero to two years related experience in biology, chemistry/pharmacy, or similar lab environment. GLP experience preferred. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None. Other: This position requires analytical thinking skills and a good understanding of scientific processes. Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. Knowledge of GLP regulations and understanding of routine study design and protocols. Comments: This position requires overtime, weekend, holiday, and/or after hours shift coverage, as needed. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit ***************

Title: Scientist/Senior Scientist Reports To: Study Director Manager Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary We are currently looking for a scientist/senior scientist to be located on-site at our Concord, OH toxicology facility to develop in vitro toxicology assays and new approach methodologies (NAMs). Scientists at Frontage Laboratories serve as technical experts and consultants in in vitro toxicology and related fields, working in a collaborative environment on projects throughout the discovery and development continuum and have a passion for science and quality. The ideal candidate will have knowledge of New Approach Methodologies (NAMs) to replace or reduce the use of animals in drug development and to refine the use of animals to achieve better results.in vitro toxicology. Experience in regulatory toxicology and familiarity with Good Laboratory Practices (GLPs) and drug development is preferred but not required. Roles & Responsibilities * Knowledge and Experience: Full knowledge of New Approach Methodologies (NAMs) for use in toxicological research and implement NAMs in drug development processes. * Method Development & Validation: Hands-on experience in developing, optimizing, and validating novel in vitro toxicology platforms (i.e., cell cultures, organoids, or high-throughput systems). * Laboratory Execution: Performing experiments using modern instruments including but not limited to flow cytometry and plate readers, etc. * Data Interpretation & Reporting: Interpreting and reporting experimental data; familiarity with computational modeling and statistical analysis. * Scientific and Regulatory Compliance: Ensuring all experimental activities adhere to guidelines and supporting regulatory submissions by providing data that can waive or reduce the need for animal testing. * Collaboration and Communication: Working closely with collaborators; Demonstrating scientific leadership through participation in professional organizations, presentations, and publications. * Additional Responsibilities: Performing additional duties and tasks assigned by the Management. Qualifications/Requirements: * Master or PhD in cell biological sciences or related fields. * Preferably (3+ years) experience of in vitro toxicology in a CRO, pharmaceutical, or biotechnology setting; however, qualified candidates with other relevant experience are encouraged to apply. * Proficiency in techniques such as cell culture, molecular biology, and biomarker development. * Knowledge of NAMs and AI tools in drug discovery and development. * Strong, effective written and oral communication skills, including the ability to organize and clearly present complex data and concepts. * Ability to work in a fast-paced environment, manage multiple projects, demonstrate consistent productivity, and meet project timelines. * Ability to work independently and collaboratively. Salary and Benefits * Frontage Laboratories offer a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, short and long‑term disability insurance, life insurance etc. * Concord, Ohio is a township about 30 miles east of Cleveland. The housing is more affordable than many areas close to major cities and is nestled in a rural setting, yet with good restaurants, shopping, and schools within the township. We consider the lifestyle and proximity to attractions in Cleveland to be a hidden benefit of living and working in Concord. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: In this role you are responsible for microbiology related analysis including but not limited to in-process, drug substance, raw material and water sample endotoxin analysis. Responsibilities include but not are limited to: Ensuring that suitable written records and work undertaken are kept in accordance with cGMP and company procedures. Working within various internal departments to improve and execute processes used in an ICHQ7 environment. Assisting with OOS/OOT investigations and root cause analysis investigations. Interacting with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers. Maintaining and updating relevant Ops. Who You Are: Minimum Qualifications: Bachelor's Degree in Biology, Chemistry, or other Life Science discipline. 1+ years of QC lab experience, specifically in Bioburden (USP), Growth Promotion Testing, and Endotoxin analysis. Preferred Qualifications: Experience with aseptic technique and practices. Experience with SOPs, cGMPs, GLP, GDP and quality control processes. Experience with basic scientific/regulatory principles such ad ICH Q7, 21CFR210/211, USP and EP. Strong written and verbal communication skills. Strong multi-tasking skills and teamwork mindset. Strong computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint. Good problem-solving and time management skills. Strong attention to detail and organizational skills. Current API knowledge and/or experience. Experience writing technical documents, reports, and troubleshooting. Pay Range for this position: $23 - $42 / hour The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!