Catalent Pharma Solutions jobs in Chelsea, MA - 56 jobs

**Quality Assurance Specialist II, Operations (Night shift, on-site)** + **Work Schedule:** Night shift 7-day rotating 12-hour shift with hours between 6pm-6am, 2-2-3-2 schedule, often referred to Pitman schedule. This shift offers 15% differential pay + 100% on-site (Chelsea, MA) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and the Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is hiring a Quality Assurance (QA) Specialist II. The Quality Assurance Specialist II is responsible for supporting daily operations in a GMP (Good Manufacturing Practices) Manufacturing Facility. This individual provides oversight of production activities with limited supervision. **The Role:** + Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of discrepancies + Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities + Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities + Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement. Initiation of Discrepancies, including Deviations and Investigations. Support of implementation of CAPA as determined through Discrepancies + Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods. Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials) + Provide basic support during compliance inspections conducted by external sources (i.e. health authorities). Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators + All other duties as assigned **The Candidate:** + High School Diploma/GED is required with at least five (5) years of progressive experience in a GMP environment + Bachelor's degree in a scientific discipline is preferred with a minimum of three (3) years of progressive experience in a GMP environment + Minimum of one (1) year of Quality Assurance experience in support of GMP production required + Working knowledge of GMPs and their application to pharmaceutical manufacturing is required. Must be able to interpret applicable standards and objectively make decisions with the support of management + Previous exposure to investigations and product complaints preferred + Must be proficient in Microsoft Office Suite, and experience with Material Requirements Planning (MRP) systems or Quality Management Systems (QMS) is preferred + **Physical requirements:** Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds **Pay:** + The anticipated salary range for this role in Massachusetts is $72,781 to $96,069 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

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 an experienced Animal Care Technician II to join our Insourcing Solutions team, located in Boston, MA. As the Animal Care Technician II, you will review, observe, monitor and document the health and physical environment within the client's animal facility. You will perform animal care and husbandry duties, including receiving, cage washing, and sanitation, ensuring the highest standards of animal welfare and compliance. Additional responsibilities include: * Monitor daily animal health and welfare; perform health observations. * Conduct animal husbandry tasks: feeding, watering, cage changing, and cleaning. * Perform cage wash duties and sanitation per established schedules. * Operate and maintain equipment (cage washer, autoclave, water systems). * Maintain accurate records of animal breeding, health, and housing. * Assist with restraint, handling, and manipulation of various species. * Receive, inspect, and house incoming animals. * Use software for animal tracking and census. * Follow safety guidelines and maintain a clean work environment. * My participate in breeding and weaning procedures; manage small breeding colonies. * Perform quality assurance measures (temperature checks, water testing, etc.). * Adhere to attendance and scheduling requirements, including weekends and holidays on a rotating basis. Job Qualifications To qualify for this role, candidates must have one of the following combinations of education/experience: Bachelor's degree in Animal Sciences, or Life Sciences or similar field and 1 year related experience in a AALAC laboratory animal facility OR Associates Degree in Animal Sciences, or Life Sciences or similar field and 1.5 years related experience in a AALAC laboratory animal facility OR High School Diploma or GED and 2 years related experience in a AALAC laboratory animal facility Certification/Licensure: AALAS Certification at the ALAT level or above. The pay range for this position is $24 to $26 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231743

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE 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 As an Animal Care Associate for our GEMS Breed Group in Wilmington, MA. The GEMS Animal Care Associate will learn how and continue to maintain and monitor the health, production, and physical environment of client or Charles River Laboratories (CRL) animals housed at CRL facilities. These environments may include isolators or individual ventilated cages (IVC). * This is a temporary opportunity with the potential to be hired as a full-time, employee* ESSENTIAL DUTIES AND RESPONSIBILITIES: * Perform entry-level husbandry tasks, including supplying food, bedding, water and environmental enrichment. * Maintain rat and mouse colonies, including setting up matings, weaning and sexing of offspring, genetic sampling of animals. * Handle rodents (mice and rats), including restraining of animals for collection of fecal pellets, ear/tail sampling as well as tagging animals for identification. * Observe animals for any abnormalities or common health issues. * Identify and select specific animals for customer shipments, genotyping, health monitoring, matings, transfers or other various tasks as needed. * Learn, understand, and comply with all Standard Operating Procedures (SOPs) with direct supervision and instruction for most processes/tasks. * Learn and strictly follow all animal welfare standards and biosecurity procedures necessary to maintain isolator integrity and animal health status, including the proper sterilization and entry of supplies/animals into isolators. * Be detailed-oriented and enter accurate data entry into Internet Colony Management (ICM). * Ensure compliance with all local, state and federal laws governing the use of research animals. * Ability to prioritize and execute daily tasks with guidance from supervisor(s). * Perform general housekeeping and adhere to EHS, safety, and ergonomic procedures. * General computer skills and ability to quickly learn required computer programs, databases and other applications (i.e. ICM and Microsoft Office) * Be able to learn to identify issues and communicate to management and learn the importance of our CRL DNA and core values. * Perform all other related duties as assigned. Role Specific Information: * Location: Wilmington, MA * Schedule: Monday - Friday - 1st shift, no weekends required * Benefits: Paid Sick Time/Volunteer Time Off and use of our gym onsite MINIMUM QUALIFICATIONS * Experience: Entry-level, no previous experience required. * Sufficient computer knowledge to use a tablet computer and communicate using Microsoft Applications. * The ability to develop knowledge of, respect for, and skills to engage with those of other cultures or backgrounds. * The ability to communicate clearly and effectively. PREFERRED QUALIFICATIONS * Certification/Licensure: AALAS certification at the ALAT or above. The hourly pay rate for this position is $18.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Research Models & Services Fundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition. As the world's leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal models produced for preclinical research globally, we understand the importance of this step. With seven decades of experience, our expertise is unmatched, allowing us to provide you with the perfect model, including disease-specific and preconditioned options, for basic research and beyond. 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 *************** 231776

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 Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Assure Charles River's compliance with applicable GLP . Communicate all identified compliance and quality risks to supervisor. * Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, SOPs, and protocols. * Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations. * Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management. * Identify deviations from GLP regulations, protocols and SOPs. * Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations. * Assist in scheduling and tracking QA audits, inspections and procedures as requested. * Perform all other related duties as assigned Note: The pay range for this position is $60,000 - $64,000 annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location Job Qualifications QUALIFICATIONS: * Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline. * Experience: 1-2 years experience in QA role * 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: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing. PHYSICAL DEMANDS: * Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. * Must regularly communicate with employees/customers; must be able to exchange accurate information. * Must occasionally move about inside the office to access file cabinets, office machinery, etc. 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231445

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 Research Associate to join our Insourcing Solutions team, located in Cambridge, MA. As the Research Associate, you conduct in vivo study work in rodents for multiple IS clients to support research programs. Collaborate with the veterinary staff to ensure the health and welfare of laboratory animals are maintained in compliance with guidelines and regulations. Additional responsibilities include: * Able to perform and obtain competency/proficiency in the following techniques, at minimum: * Handle and restrain animals using appropriate procedures * Formulation and dosing calculations * Dosing and inoculation of test articles via basic techniques ( e.g., oral gavage, intravenous, subcutaneous, intraperitoneal, etc.) * Basic tissue (e.g.; spleen, liver, etc.) and blood collection (e.g., cardiac puncture, intravenous, etc.) * In-life monitoring of the study animals for body weights, clinical observations, tumor measurements, etc. * Monitors animal health and welfare while performing technical procedures. * Perform study preparation activities, including but not limited to, IACUC and study protocol review, collection tube labeling, and room setup. * Conduct laboratory procedures in compliance with approved IACUC protocols and study plans. Job Qualifications To qualify for this role, candidates must have one of the following combinations of education and experience. Option 1: * Required: High School Diploma or GED AND either 1) a minimum of 2+ years of lab animal experience or 2) Certification from AALAS, at minimum the ALAT. Preferred: Basic in vivo technical skills. Option 2: * Required: A.A./A.S. or B.A./B.S. in animal or laboratory (life) sciences or related discipline AND a minimum of 6-12 months lab animal experience. Preferred: Basic in vivo technical skills; ALAT certification. The pay range for this position is $29 to $32 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231013

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 an Inside Sales Representative for our Biologics business unit to be located on the East Coast, in the U.S and work remote from a home office. The Inside Sales Rep. is responsible for driving Biologics sales and serving as the point of contact for all sales customer inquiries. The Inside Sales Rep administers the sales process for specific Biologics accounts and/or sales opportunities via phone and e-mail. The role involves engaging with existing customers and qualified sales leads while guiding customers to Biologics products and services that best meet their needs. The following are responsibilities related to the Inside Sales Rep: + Drive with customer follow-up and developing/closing Biologics opportunities. + Point of contact for all sales customer inquiries and outbound prospecting. + Engage with existing customers and generating sales opportunities. + Establish new customers and maintain/grow existing customer accounts. + Establish and nurture positive, productive relationships with customer accounts + Work collaboratively with Marketing to drive product promotions and provide feedback on ROI. + Share customer problems/concerns with relevant departments for quality resolution. + Attend tradeshows routinely and aid in coordination of tradeshow events and or presentations. + Participate in Global Sales meetings as required. + Complete all required sales documentation in a timely manner. + Maintain a CRM database via updates to sales opportunities, sales stages, marketing statuses, and customer intelligence data. **Job Qualifications** The following are minimum qualifications related to the Inside Sales Specialist position: + Bachelor's degree in a science or technical field required. Biology, Biochemistry, Genetics, Molecular Biology, chemistry strongly preferred. + 2-4 years of successful sales experience with a technical life science product preferred. + Demonstrated ability to quickly grasp and master highly technical concepts and articulate them well to others. + Outstanding listening, verbal, presentation, and written communication skills. + Strong interpersonal skills with the ability to communicate effectively with a wide range of customer personality types. + Strong ability to identify customer needs, obstacles to the sales process, and solutions using Charles River products and services. + Proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint) + Experience working with Salesforce, Microsoft Dynamics or a similar CRM database a plus. + Strong business sense, instinct, and personal drive. + Team goal oriented with a focus on achieving team sales performance metrics through personal contribution and teamwork **Compensation Data** The base pay range for this position is $33/hr. - $40/hr. USD + commission. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **Competencies** Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 supported the development of 86% of the drugs approved by the FDA in 2021. **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, or national origin, veteran or disability status. 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 *************** 231516

For over 75 years, Charles River employees have worked to advance the discovery, development, and safe manufacture of new drug therapies, making a profound impact on global health. Our 10+ year partnership with Novartis takes this mission to the next level, supporting innovative medicines that reach 296 million people worldwide. At Novartis, their commitment to diversity drives the exceptional quality of reimagined medicines which improve and extend people's lives. This is your moment to become part of a family where unique talents and perspectives unite to change lives, including your own. Together, we're shaping a healthier future through compassion, innovation and opportunity. Job Summary We are seeking an Central Services Technician I (Cagewash) to join our Insourcing Solutions team located in Cambridge, MA. As the Central Services Technician I, you will be responsible for the overall sanitation of cages and related equipment, including cage wash rooms, feed and bedding rooms, hallways, loading docks and other specific areas. Responsible for receiving feed, bedding and other supplies. All specific duties are to be performed in accordance with all regulations pertaining to federal, state, local (Animal Welfare) laws and departmental SOPs pertaining to Good Laboratory Animal Practices. * Work schedule - Monday-Friday - 7:00 am - 3:30 pm ESSENTIAL DUTIES AND RESPONSIBILITIES: * Removes dirty bedding and other items from shoe boxes * Performs cage and other related equipment sanitation * Flushes water cage manifolds * Operates washers and ensures that cage washing and related equipment are in proper working order * Performs daily start-up and shut down procedures of the cage washer * Operates autoclave to sterilize or decontaminate caging equipment and other related equipment * Transports caging and equipment between animal areas and cage wash rooms and vice versa * Performs sanitation of cage wash rooms and other ancillary areas, such as hallways, feed, bedding and storage areas * Organizes and manages documentation * Removes trash and waste according to safety guidelines * Read and understand all SOPs related to assigned duties * Receives and stores animal feed, bedding and supplies; records and files the appropriate information * Sanitize empty animal room(s) and labs * Inspect enrichment devices, cages and other items * Conducts and collects various aseptic sampling for the monitoring of water quality, sanitized animal racks and equipment * Perform all other related duties as assigned MINIMUM QUALIFICATIONS: The following are minimum requirements related to the Central Services Technician I position: * High School Diploma or G.E.D. * Zero-six months experience working in a laboratory animal facility performing cage wash duties or working with glassware cleaning or a commercial dishwashing operation or operating large equipment. KNOWLEDGE, SKILLS & ABILITIES: * Knowledge of industrial equipment operation safety * Working knowledge of federal, state, local (Animal Welfare) laws, departmental SOPs and regulations pertaining to Good Laboratory Animal Practices. Initiative for solving minor problems * Must demonstrate strong verbal and written communication skills * Fundamental knowledge of computer applications (Microsoft Word, Excel and Email) * Must be able to represent Laboratory Animal Services department in a professional manner The pay range for this position is $21.39 - $23.50 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231900

**Manufacturing Technician (Night Shift)** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturing Practices (CGMP) unit of its kind for DPI in North America. Catalent Pharma Solutions in Boston is hiring a Manufacturing Technician. The Manufacturing Technician assists in the performance of routine operations for the GMP production of pharmaceutical products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines. The Manufacturing Technician executes production activities under direct supervision for the Spray Drying of Active Pharmaceutical Ingredients. **This is a full-time, on-site, hourly role. Work schedule will be a 7-day rotating 12-hour schedule from 6:00 p.m. to 6:00 a.m. Week 1 will be 48 hours over 4 days, and week two will be 36 hours over 3 days (often referred to as a Pitman Schedule). Overtime and Holiday pay will be included.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Performs Clean-In-Place, Clean-Out-of-Place, and equipment decontamination as required + Operates and monitors manufacturing equipment for the production of clinical and commercial pharmaceutical products + Assists in the execution of routine and complex production processes + Completes GMP documentation in legible and organized fashion + Receives and distributes supplies in the manufacturing area + All other duties as assigned **The Candidate:** + A High School Diploma or equivalent is required. Biotechnology Certificate or Associate's Degree is highly desired + Must have at least one (1) year of prior work history, preferably in a Manufacturing Environment + Working knowledge of Good Documentation and Good Manufacturing Practices preferred + Must be proficient in Microsoft Office Suite + Physical requirements: Individual may be required to sit, stand, walk regularly, use hands regularly, and occasionally lift up to 50 pounds **Pay:** + The anticipated salary range for this role in Massachusetts is $52,000 to $62,700 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

For 75 years, Charles River employees have worked to advance the discovery, development, and safe manufacture of new drug therapies, making a profound impact on global health. Our 20-year partnership with Boston Children's Hospital takes this mission to the next level, supporting groundbreaking innovations that directly impact patient care. At Boston Children's, their commitment to diversity drives the exceptional quality of care provided to patients from local communities to over 160 countries worldwide. This is your moment to become part of a family where unique talents and perspectives unite to change lives, including your own. Together, we're shaping a healthier future through compassion, innovation, and opportunity. We are seeking an experienced Rodent Veterinary Technician to join our Insourcing Solutions team, located at Boston's Children's Hospital. This is a full-time opportunity, Monday-Friday with periodic holidays and weekends. JOB SUMMARY In the Rodent Veterinary Technician role, you will work closely with the veterinarian(s) to perform daily health assessments, maintain records and provide treatment to the animals on protocols. You will ensure that the health and welfare of laboratory animals are maintained in compliance with institutional, local, state and federal guidelines and regulations for Animal Resources Children's Hospital (ARCH). ESSENTIAL DUTIES AND RESPONSIBILITIES: * Provide technical skills training to the research community in support of approved protocols to include animal handling and restraint, weaning, tail snips, ear tagging, blood and other tissue sample collection, injections, treatments, surgical preparation, pre-, peri- and post-operative observations. * Coordinate and process orders for animal medications (anesthetics, analgesics, antibiotics, etc.) and will document distribution of medications and provide guidance on recordkeeping. * Work closely with the veterinarian(s) to perform daily health assessments of laboratory animals and maintain all records as needed and associated with this monitoring. Provide animal treatment according to standard operation procedures or otherwise as instructed by the veterinarian(s). * Provide training for the staff as it relates to animal care and health. * Conduct routine inspections of animal holding rooms to ensure the health and well-being of the animals and will prepare and submit written reports, monthly billing summaries (drug orders, overcrowded cage charges) as requested. * Perform other duties as assigned. MINIMUM QUALIFICATIONS: * A.A./A.S. in veterinary technology, animal science or equivalent college level program. * 6 to 12 months animal handling in a research laboratory environment as well as veterinary technical skills. * The ability to successfully achieve AALAS certification at the Assistant Laboratory Animal Technician level (ALAT) or higher within 1 year. * Proficient in computers (MS Office Suite). * Excellent verbal and written communication skills. * Proof of current vaccinations for both COVID-19 and Influenza. PREFERRED QUALIFICATIONS: * B.A./B.S. in animal science. * AALAS Certification at the ALAT. CVT or LVT. The pay range for this position is $35.00 to $37.00 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. 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, or 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 *************** 230523

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** The Compliance Associate will report to the Executive Director, Corporate Compliance and Ethics, and and working in close partnership with Legal, functional and business area key stakeholders, this position will support all corporate (non-regulatory) compliance activities to assure the development, implementation, and management of a comprehensive Legal Compliance program. The Charles River Legal Compliance program is designed to ensure compliance with national, state and local laws/regulations in each jurisdiction in which the Company operates globally, and to promote the Company's goals, mission and values. Responsibilities include assisting in planning, implementing, maintaining, managing, monitoring and auditing the Company's Legal Compliance program; managing compliance-related training and communications; monitoring compliance by third parties; identifying legal issues and opportunities; assessing risks, benefits and consequences of legal compliance; measuring the effectiveness of policies and training; and recommending appropriate This position will work remote from home office and must be able to work East Coast hours. **Essential Duties & Responsibilities** * Training: + Supports the day-to-management of Charles River's global Legal Compliance training program, including assisting with curriculum planning, identifying key risks and topics for training, managing data, enrollment and distribution of initiatives, reporting on progress of activities, and partnering closely with other business and functional areas (e.g., Legal, HR, Communications, etc.). * Communication: + Helps manage Charles River's global Legal Compliance communication program, including developing and launching company-wide newsletters, organizing Legal Compliance promotional videos and events (including our annual Compliance Day) and managing other global outreach efforts. Also serves as a primary point of contact for individuals within business and functional areas by overseeing the Legal Compliance program's intranet site and email inbox. * Third Party Risk Management: + Assists with the monitoring and review of Charles River's third parties to help ensure third parties' compliance with applicable laws, regulations and Company policies and to mitigate risk for Charles River (e.g., anti-bribery and anti-corruption). * Risk Assessment: + Supports the execution of Charles River's annual compliance and ethics risk assessment by coordinating data gathering with risk owners and key stakeholders, compiling data, assisting in the review and analysis of data and developing a risk assessment report for key stakeholders. * Policies and Procedures: + Assists in the development, implementation and maintenance of Legal Compliance program policies and procedures (including the Code of Business Conduct and Ethics) by partnering with business and functional areas to develop updated and / or new policies and procedures, adhering to the Charles River Policy Management Process, planning communication and / or training on policies and procedures, and coordinating rollout of new and / or updated policies and procedures. * Reporting and Issue Management: + Helps address compliance and ethics-related questions or reports by maintaining our case management tool and conducting appropriate investigative or follow-up activities. **Job Qualifications** Education: + Bachelor's degree (B.A./B.S.) or equivalent Experience: + Minimum of two (2) years in a corporate ethics and compliance function + Familiarity with compliance-related laws and regulations (e.g., Foreign Corrupt Practices Act) + Experience in a team-based organization + Strong organizational and project management skills (including project planning) + Ability to navigate diverse business, cultural and interpersonal environments + Analytical skills and the ability to demonstrate critical thinking Preferred Qualifications: + Quantitative skills necessary to analyze data + Experience with, or interest in, Data Privacy + Experience in the life sciences and / or related industry sector Compensation Data The pay range for this position is $75,000 - $85,000K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231489

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 highly motivated and experienced Sr. Business Development Director to lead sales efforts for our non-human primate (NHP) portfolio, targeting pharmaceutical companies and contract research organizations (CROs). This role is critical in driving revenue growth, building strategic partnerships, and ensuring ethical and compliant practices in the sourcing and distribution of NHPs for preclinical research. Key Responsibilities: * Develop and execute a strategic sales plan to expand our NHP business within the pharma and CRO sectors. * Identify, qualify, and close new business opportunities with key decision-makers in R&D, procurement, and lab operations. * Build and maintain strong, long-term relationships with clients, understanding their research needs and aligning our offerings accordingly. * Collaborate with internal teams (logistics, compliance, veterinary, and operations) to ensure timely and ethical delivery of NHPs. * Stay current on industry trends, regulatory changes, and competitor activity to inform strategy and maintain a competitive edge. * Represent the company at industry conferences, trade shows, and client meetings. * Maintain accurate records of sales activities, forecasts, and customer interactions in CRM systems. **Job Qualifications** * Bachelor's degree in life sciences, business, or a related field; advanced degree preferred. * 5+ years of experience in life sciences sales, preferably with experience in animal models or preclinical research services. * Deep understanding of the pharmaceutical and CRO landscape, particularly in preclinical development. * Knowledge of regulatory and ethical considerations related to the use of NHPs in research. * Strong interpersonal, negotiation, and communication skills. * Ability to travel domestically and internationally as needed. Preferred Experience: * Prior experience selling NHPs or other research animals. * Existing network within pharma R&D and CRO procurement teams. * Familiarity with import/export regulations and animal welfare standards. Compensation Data The pay range for this position is $120K - $160K USD annually + commission. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231329

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** The Senior Analyst, Internal Controls is responsible for supporting ongoing compliance efforts of the Global Internal Controls department under the Company's Sarbanes-Oxley (SOX) 404 compliance program to ensure financial integrity and systems controls are properly designed to prevent or detect errors in financial reporting. This individual will apply the company's risk-based methodology to prioritize processes for review and formal documentation in alignment with CRL documentation standards and provide guidance on internal controls best practices aligned with group policies, rules, and regulations. This position will work remote from home office, but must work Eastern time zone hours. Occasional domestic or international travel is possible. ESSENTIAL RESPONSIBILITIES INCLUDE: * Work with Manager and team in facilitating the SOX 404 Program including scoping, setting the global calendar, orchestrating and executing limited sample testing on behalf of management, summarization and communication of test results, etc. * Manage and perform internal compliance routines and assessments to ensure ongoing compliance with the Sarbanes-Oxley Act and established internal control frameworks (COSO). * Provide oversight, technical support and guidance to ensure that the company's financial controls and supporting records are prepared in accordance with company policies and Generally Accepted Accounting Principles. * Serve in an advisory capacity and provide subject matter expertise on internal controls to business stakeholders. * Ensure controls are designed to address process and financial statement line item risks through discussions, process walkthroughs and limited control testing, resulting in recommendations for modification and improvement. * Assess and implement formal SOX compliance plans, timelines and implementation of controls by collaborating cross-functionally. * Support internal quality control process to assess top SOX risks, establish risk mitigation strategies, present recommendations to director and senior director, and perform pre-audit testing and remediation on behalf of management. * Provide internal controls support for automation and other efficiency projects and assess changes to the internal control environment, evaluate risks, design suitable controls, train stakeholders, test and remediate controls. * Administer the company's SOX compliance system * Evaluate operating deficiencies identified during testing and work with responsible groups to remediate them timely. * Document processes, risks and controls by leveraging Microsoft Visio, Word, PowerPoint and Excel. Partner with management in the identification and implementation of process and control improvement initiatives to enhance the effectiveness and the efficiency of the Company's business process controls. * Facilitate internal and external audits; track, monitor and report on all reported deficiencies to ensure timely correction. Seek improvements in the Company's control environment to ensure effectiveness and operational efficiency. * Assist with implementation of shared service center initiatives and organizational structure design to optimize quality workflow and ensure proper segregation of duties. * Perform all other related duties as assigned. **Job Qualifications** * Bachelor's degree in accounting, finance or other business related major. * 6 to 8 years of experience in Big 4 public accounting and private industry. * Ability to build and maintain solid relationships across multiple levels of management including communication with external auditors/consultants. * Strong knowledge of the requirements of the Sarbanes-Oxley Act, Section 404, US GAAP applicable to the technology industry, SEC reporting requirements, and PCAOB and COSO/Internal Audit standards. * Strong operational capability and sense of urgency to drive assigned tasks to completion to ensure achievement of annual departmental initiatives. * Willingness to roll up sleeves to complete assigned deliverables timely. * Demonstrated ability to work and multi-task in a fast-paced/high growth environment with multiple entities. * Strong international and inter-cultural experience. * Ability to prioritize the most critical areas and issues with an accomplishment-focused mindset. * Experience establishing a SOX controls program that address a combination of financial/operating and technology objectives. * Familiarity with financial systems and technology, SAP S4 HANA, Blackline, Auditboard, Smartsheets and PowerBI. * Excellent written, verbal, and presentation skills. * One or more current qualifications preferred - CIA or CPA. **Compensation Data** The pay range for this position is $100K - 120K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Corporate Functions** The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. **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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 230936

We are looking to fill a **Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience** 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.** **Description** Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Other potential opportunities include method development/optimization, workflow optimization, and template development. **Responsibilities** + Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing + Results processing and documentation by following appropriate methods / protocols / procedures + Sample management and monitoring of controlled temperature units. + Following all appropriate laboratory safety and hygiene procedures **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab + MS (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab **Required Skills and Experience** + Must have separations experience for large molecules or plate-based assay experience. + Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques: + Liquid Chromatography (HPLC / UPLC) + Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) + Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF) + ELISA (HCP, proA) and binding potency assay + qPCR and basic molecular biology techniques (gel electrophoresis, etc.) + High-throughput liquid handling system, e.g., Tecan, Bravo, etc. + Basic instrumentation troubleshooting + **Ability and willingness to train in molecular biology and immunoassay testing** + **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)** **Desired Skills and Experience** + Familiarity with compendial testing such as UV 280, pH, and Physical Observations + **Ability to follow complicated scientific protocols / procedures** + Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases) + Good documentation practices & utilization in electronic lab notebooks (ELN) + Analytical software such as Empower. + Knowledge of Laboratory Information Management Systems (LIMS) + Sample submission & sample management + Monitoring of controlled temperature units + Experience with BSL2 (Biosafety Level 2) **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 This is a full time - 40 hours/week position. Must be able to start full time day shift within one month of offer. Perform basic laboratory support and record-keeping tasks. Support the functions of the Laboratory Sciences department. ESSENTIAL DUTIES AND RESPONSIBILITIES: Receive, monitor, and maintain inventory and stock levels of assigned areas. Operate lab equipment and perform routine maintenance as needed. May be responsible for preparing lab solutions (e.g., buffers, media/common vehicles, and bleach solutions). Wash and dry glassware and distribute to appropriate locations within the laboratory. Keep glass-washing area clean and organized. May sterilize glassware and other items using an autoclave. Label tubes and perform laboratory set-up/clean-up. Organize and perform inventory of department refrigerators or freezers. Assist in the archiving of equipment/facility records. Assist technical personnel with clerical duties (e.g., filing, making copies, shipments set-up etc.). May record observations and measurements for basic lab/research task. Perform limited troubleshooting and maintenance of instruments as appropriate for assigned area. May generate forms, tables, and hand record data. Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures (SOPs). Ship, store, and document received supplies (e.g., test articles, bio-hazard boxes, dry ice, reagents, etc.) Assist technical personnel with laboratory supplies expiry check and discard as needed. Perform all other related duties as assigned. The pay range for this position is $21.00/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Job Qualifications QUALIFICATIONS: ⦁ Education: High school diploma or General Education Degree (G.E.D.). ⦁ Experience: None. ⦁ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. ⦁ Certification/Licensure: Must have valid, state-issued, driver's license. ⦁ Other: Must be detail-oriented and have general familiarity with lab procedures. Good verbal communication skills required. Basic computer skills; familiarity with Microsoft Office software. PHYSICAL DEMANDS: ⦁ Employees must be able to regularly lift, move, or manipulate heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies. ⦁ Must be able to perform procedures, which require standing or sitting for long periods of time. ⦁ Must be able to regularly move about the facility to access file cabinets, office machinery, and other buildings. ⦁ Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. ⦁ Regularly uses laboratory instruments. ⦁ Must be able to work in narrow spaces. ⦁ Must be able to wear safety equipment (PPE), as needed, according to OSHA regulations and company standards. ⦁ Must be able to regularly stoop, bend, kneel, stand, or reach up with hands and arms to manipulate objects on shelves from one and one-half to six and one-half feet above the floor on a repetitive basis each day. ⦁ Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus. ⦁ Must be able to communicate with employees, exchanging accurate information. ⦁ Must regularly move about inside the facility to access supplies which may require going up and down stairs. WORK ENVIRONMENT: ⦁ Works in a research environment, which requires use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from moderate to loud. ⦁ The noise level in the work environment ranges from low to moderate depending upon the task being performed. 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. 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 *************** 231803

Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities. This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence cross‑functional teams in a fast‑changing environment. Key Responsibilities: Documentation & Compliance - Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements. - Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). - Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions - Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. - Provide local input for change control and post-approval requirements. - Collaborate with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support - Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. - Provide local expertise and responses to inspection queries. Cross-Functional Collaboration - Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes. - Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership - Lead regulatory strategies for product launches and integrations at the affiliate level. - Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships. - Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education - Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. - Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences. - Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience - 3-5+ years of local regulatory knowledge and experience in a health authority-facing role. - Demonstrated previous life cycle management experience is required. - Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. - Proven expertise in managing regulatory submissions, timelines, and cross-functional teams. - Strong project management and leadership skills. - Experience influencing Commercial Operations stakeholders and driving business-critical decisions. - Demonstrated ability to adapt and succeed in rapidly changing environments. \#LI-LB1 \#LI-REMOTE 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 Cagewash Technician for our Safety Assessment site located in Reno, NV. The Cagewash Technician will assist in cleaning and disinfecting animal housing, feed and water containers using the automated cage washer, and cleaning of laboratory areas. This individual will also be responsible for recording all required tasks on relevant logbook records accurately and completely. The Cagewash Technician will also assist with animal care technical duties such as changing liners and sanitizing animal room walls and floors. **Job Qualifications** The following are minimum requirements related to the Cagewash Technician position: * High School diploma or General Education Degree (G.E.D) preferred, but not required. * No experience necessary. * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. * While performing the duties of this job, the employee is regularly required to talk, hear, and lift. * Specific vision abilities required by this job regularly requires close vision and the ability to adjust focus. * Must be able to regularly lift and manipulate up to 50 pounds on a repetitive basis each day. Salary: The pay range for this position is $20.00 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **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 supported the development of 86% of the drugs approved by the FDA in 2021. **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. 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 *************** 231870

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** 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. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions in Chelsea, MA is hiring a Director of Quality who will provides leadership and daily management of the Catalent Boston Quality Department - Quality Assurance and Laboratory (Analytical Development/Quality Control). The responsibility of the role is to provide support to site operations as well as to the corporate Quality function. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * To ensure the Quality function complies with Health, Safety and Environmental requirements and employees adhere to the "Standards of Business Conduct" * As a member of the site leadership team ensure an effective Pharmaceutical Quality Management system is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated, and implemented throughout the organization; * To determine, establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements; * To ensure that the site complies with requirements of Good Manufacturing Practice; * To manage the Quality budget and ensure that adequate resources are available for the function to meet its obligations; * To liaise with other functions and departments, within the Catalent Pharma Solutions organization, on aspects of Quality and Compliance which impact products, projects or the supply chain; * To continually review the operation of the quality function on site, to provide best practice and deliver a program of continuous improvements to the methodologies/systems employed which will result in measurable operating benefits; * Other duties as assigned. The Candidate: * Bachelor's Degree in Chemistry, Biology or related scientific field required. Master's degree in Chemistry, Biology or related scientific field preferred; * A minimum of ten 10 years' experience of leading a customer focused quality function including Quality Assurance, Quality Control and batch release within a pharmaceutical GMP environment required; * Leadership experience supervising a team of managers/supervisors and analysts, scientists, and quality specialists; * Demonstrate knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience; * Demonstrated knowledge of Change management and Lean principals; * Participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA, USDA; * Ability to work under pressure to meet tight and changing deadlines; * Ability to be assertive to ensure appropriate GMP and business standards are achieved * Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience; The anticipated salary range for this position in Massachusetts is $168,750-$257,800. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why You Should Join Catalent: * Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance). * Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions. * Paid Time Off Programs including Vacation, banked time, and personal time. * Employee Reward and Recognition Programs. * Opportunities for professional and personal development. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.