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 Facility Manager II to join our Insourcing Solutions team, located in Bethesda, MD.
As the Facility Manager II, you will be the primary point of contact for the facility, utilizing existing SOPs and quality assurance standards to oversee and coordinate the daily activities of the facility within varied animal care environments, including scheduling of staff.
Additional responsibilities include:
+ Oversee the animal surveillance program and all aspects of husbandry, including technical and cage wash support.
+ Provide quality assurance to include animal health surveillance; monitoring of the effectiveness of facility sanitation, cage washing and autoclaving procedures; monitoring of incoming animal shipments for container integrity and animal health; monitor the heating, ventilation, and air conditioning (HVAC); internal facility reports for monitoring deviations from pre-established parameters; and other quality assurance services as deemed necessary (e.g., water cultures).
+ Participate in interviewing applicants for open positions, developing performance improvement plans, and writing employee performance evaluations.
+ Assist in assessing, developing, and presenting training for staff and investigators.
+ Participate in QC/QA, and ensure CAPA development, implementation, and adherence.
+ Occasionally provide technical support (e.g., restraining animals, collecting blood, collecting tissues, performing injections, treatments, surgical preparation, assisting with research procedures).
+ Occasionally provide animal husbandry and environmental enrichment.
+ Provide data entry/data base report generation for computerized systems which monitor facility internal environmental parameters, security, or other animal facility monitoring and management requirements.
+ Prepare and submit written records, charts, logs, and inventories.
+ Actively interact with Project Officers, facility veterinarian(s) and investigators to solve customer requests, inquiries, and complaints.
**Job Qualifications**
The following are minimum requirements related to the Facility Manager II position:
+ High school diploma or GED required.
+ Bachelor's degree in animal science or related preferred
+ Minimum of 6 years experience in a research vivarium facility, with at least 3 years of supervisory experience
+ AALAS certification at the Laboratory Animal Technologist level (LATG) required.
The pay range for this position is $45.00 to $47.00 USD per hour.
**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 ***************
231824
$45-47 hourly Easy Apply 1d ago
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Clinical Veterinarian
Charles River Laboratories 4.3
Charles River Laboratories job in Bethesda, MD
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 looking for a Clinical Veterinarian for our Insourcing Solutions Team located in Bethesda, MD.
As the Clinical Veterinarian, you will be responsible for providing veterinary clinical care and research support as well monitoring colony health care for animals in BSL2-3 environments.
* Manage health care for the animal colony
* Perform veterinary rounds as scheduled and provide clinical care and preventive medicine support
* Perform clinical, diagnostic and surgical support and provide anesthesia and analgesic technical expertise/advice to facilitate protocol development
* Participates in the development and execution of the preventive medicine program. May assist in sentinel animal monitoring and other monitoring programs
* Documents general and detailed reports of clinical observations, medical care and surgical treatments.
* Provide animal health care guidance for veterinary services personnel
* Ensure that internal and external applications, reports and other materials are prepared and submitted
* May participate in the response to internal/external inspections and quality assurance audits of veterinary or animal welfare type content
* Perform consultation and collaboration with PIs regarding animal care, health, welfare and treatment. May also consult on the planning, conducting and reporting of studies
* Assist with writing, review and updating facility policies, veterinary care and behavioral SOP's
* Perform literature searches relating to veterinary subject matters
* Help to ensure facility is in compliance with all applicable regulations, guidelines and standards that relate to animal care and use
* Support infectious disease research by conducting physical examinations, radiography, bronchoscopy, ultrasonography, interpretation of clinical pathology and other types of clinical procedures in BSL2, BSL3 environments
**Job Qualifications**
_Education:_
* Requires doctoral degree in veterinary medicine (DVM or VMD) from an AVMA accredited program or ECFVG certification
_Experience:_
* Two-four years laboratory animal experience with multiple species in either a residency or professional setting. Nonhuman Primate (old world and new world) experience a plus
* Must have a thorough understanding of Animal Welfare regulations and the AAALAC accreditation process
* Experience with an Institutional Animal Care and Use Committee and AAALAC is preferred
* Experience providing training to investigators, post-doctoral students, technicians and animal caretakers in a variety of procedures involving animals and the vivarium
* Preference for experience working with infectious agents in BSL 2- 3 environment
_Certification/Licensure:_
* Licensure to practice veterinary medicine in at least one U.S. state required. Ability to practice veterinary medicine in the work state highly desirable
* ACLAM board certification preferred or acquisition within two years of hire required
The salary range for this position is between $165K-$190K.
**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 ***************
231785
$165k-190k yearly Easy Apply 2d ago
Associate Director - Medical Science Liaison - Dermatology- Washington DC/Baltimore
Eli Lilly and Company 4.6
Baltimore, MD job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Orgainzation Overview
At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
Purpose
Scientific and Clinical Experts (SEs/CEs) are individuals who are noted for their expertise in a therapeutic area and as a result have special needs for in-depth and cutting-edge information, because they treat patients, design and implement novel research, and educate colleagues and students. The Medical Science Liaison (MSL) program is specifically designed to meet these needs through a field-based group of medical professionals with deep content knowledge about specific disease states, Lilly and competitive compounds and the landscape within the therapeutic areas they represent. MSLs recognize and communicate feedback and insights of strategic importance from their interactions with SEs and CEs, to better inform Lilly's strategic direction for research and commercialization. By facilitating scientific exchange between industry and the scientific community, MSLs have the opportunity to shape the future of healthcare by providing needed information that addresses important clinical and scientific questions.
Responsibilities
Scientific knowledge
MSLs will be required to engage in continuous learning to maintain the highest level of technical expertise within the therapeutic area they represent. This will enable the MSLs engagement in scientific exchange to respond to the diverse medical information needs based on customer requests. As a result, the MSL will establish themself as a reliable, trusted, resource of unbiased, accurate, up-to-date, medical and scientific information requested by their customers.
Customer engagement
MSLs will spend the majority of their time on customer facing activities. Through the application of emotional intelligence, strategic thinking and a deep understanding of their customers, MSLs will act as one of the primary interfaces between Lilly medical and SEs/CEs to deliver a positive customer experience and utilize MSL capabilities that enhance customer engagement. Additionally, MSLs connect SEs/CEs with other Lilly resources or internal business partners as appropriate and facilitate collaborative research and external opportunities.
Territory ownership
MSLs will be expected to demonstrate strategic analysis, planning, and prioritization to maximize efficiency. They will implement and evaluate a strategic territory plan prioritizing core MSL activities and take personal accountability for results. There is also an expectation for compliant partnerships across all Lilly field roles sharing customers to create an appropriately coordinated experience. MSL will effectively utilize territory analytics for customer identification and routing prioritization.
Strategic vision and leadership
MSLs effectively synthesize and communicate actionable customer/clinical insights to internal Lilly medical and cross functional teams. MSLs use good judgement in decision-making and escalate issues as appropriate. They cultivate internal networks and collaborate effectively across functions including working closely with other field-based colleagues. They embrace change, exercise strategic agility with evolving business needs and utilize innovative resources.
MSLs should demonstrate the Team Lilly Behaviors (Include, Innovate, Accelerate, and Deliver) at all times in their work with peers and other Lilly colleagues. Within their own team, MSLs are expected to contribute to team goals and be an effective teammate. The MSL will execute the role in a compliant manner, adhering to all governing internal and external requirements, procedures, and laws, demonstrating good judgement at all times.
Basic Requirements:
* Advanced degree in health sciences (e.g., PharmD, MD, PhD in a medically related field) required with 2-3 years of relevant clinical or therapeutic area experience desired. OR
* Masters or bachelor's level degree in health sciences (e.g. BSN, RPh, PA, NP) considered if 5 or more years clinical, research or industry experience in relevant therapeutic area is present.
* Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
* Valid U.S. driver's license and acceptable driving record.
Additional Preferences
* Dermatology therapeutic area experience is strongly preferred.
* Field based position requires ability to travel up to 80% and work up to 4 to 6 weekends a year.
* Applicants should live in close proximity to a transport hub (airport/train station).
* Intellectual curiosity about the field of science/medicine for which they are responsible.
* Learning agility to comprehend and effectively communicate large amounts of complex scientific content in a clear and concise fashion.
* Self-directed and able to work alone in the field effectively managing multiple priorities and projects.
* Advanced presentation and computer skills with expertise in literature identification.
* Effective strategic and critical thinking in order to analyze, assess and evaluate information and interpret impact or relevance to future states.
* Excellent verbal and written communication skills.
* Ability to use field-based electronic or other communication tools for all aspects of job is critical.
* Resiliency in managing complex challenges.
* Strong teamwork and interpersonal skills, including high emotional intelligence and the ability to engage in professional relationship building and networking.
* Experience in servicing customer needs for complex information.
* Significant experience in professional networking with mutually beneficial outcomes.
* Experience in field based working environment highly valued.
* Familiarity with health systems, academic communities, medical research, and medical education process highly valued.
#WeAreLilly
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $244,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-244.2k yearly Auto-Apply 10d ago
Animal Caretaker III (50)
Charles River Laboratories 4.3
Charles River Laboratories job in Bethesda, MD
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 looking for an experienced Animal Care Technician III for our Insourcing Solutions Team in Bethesda, MD.
As the Animal Care Technician III, you will maintain, monitor, and document the health, breeding colony production, technical support, and physical environment within the customer's varied animal care environments.
Additional duties include:
* Monitors daily animal health and welfare while performing daily animal health observations and animal husbandry duties to maintain quality and health of research animals, to include but not limited to perform daily water bottle /automatic water line and cage checks; provide appropriate food and water; perform cage changing and/or cage cleaning, utilizing microisolator techniques, as required; record animal health concerns per SOP and/or specified protocols
* Reviews, comprehends, and complies with all SOP's and quality assurance standards pertaining to specific area. Cares for and maintains laboratory animals in accordance with the Animal Welfare Act and the 'Guide for the Care and Use of Laboratory Animals', as well as NIH policies and guidelines and other pertinent regulations and policies
* Performs technical support to include but not limited to animal handling and restraint, weaning, tail snips, ear tagging. May assist with blood collection (retro-orbital sinus, tail vein, cardiac bleeds on mice, rats, and rabbits), tissue samples, perform injections (IP, IM, SG, IV) treatments
* Maintains accurate records of animal breeding, health, weaning, identification, and housing/isolator or support areas as required by Institute and facility. Follows breeding and weaning procedures to ensure required production levels
* Provides environmental enrichment feed and other enrichment stimuli and /or provides behavioral assessments.
* Receives, inspects, and puts away incoming animals and complete related receiving duties
* Operates equipment and uses supplies according to safety guidelines; performs general housekeeping and adheres to safety procedures
* Assists with receipt, stocking, maintenance of supply inventories and possible cage changes
* Ability to take on new tasks and perform daily routines with minimal supervision
**Job Qualifications**
The following are minimum requirements related to the ACT III position:
* Education: High school diploma or general education degree (GED).
* Experience: Minimum of two years' experience working in a lab animal environment with direct hands on with a variety of species, and at least six months of breeding technical experience.
* Certification/Licensure: AALAS certification at the Assistant Laboratory Animal Technician level (ALAT)
The hourly range for this position is $25-$27/hour. Schedule: Monday through Friday 7AM-3:30PM. Must be available some weekends and holidays.
**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 ***************
231665
$25-27 hourly Easy Apply 12d ago
Statistical Programmer II
Parexel 4.5
Annapolis, MD job
**Unlock the Power of Data in Clinical Research!** Are you passionate about transforming complex data into actionable insights? Join Parexel as an **Analytical Data Science Programmer Consultant** **/ Statistical Programmer II** and play a pivotal role in advancing drug development. In this dynamic position, you'll collaborate with industry experts to create high-quality, traceable programming deliverables-ranging from statistical outputs to interactive dashboards-while ensuring compliance with global standards.
Bring your expertise in SAS, R, and CDISC standards to a team that values innovation, precision, and scientific impact. If you thrive in a fast-paced environment and want to make a difference in oncology research, this is your opportunity to shine!
**Ready to elevate your career? Apply today and help shape the future of clinical data science.**
The Analytical Data Science Programmer Consultants support Project Lead ADS for transforming statistical analysis plans into high-quality, traceable programming deliverables. This includes both static and dynamic outputs, such as tables, listings, figures, and interactive data visualizations or dashboards. The role involves creating and validating datasets in accordance with Study Data Tabulation Model and Analysis Data Model standards, ensuring compliance with client standards.
Job Description
**Responsibilities:**
+ Work with Project Lead ADS to develop, validate, and maintain datasets and statistical outputs for clinical trials, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), ensuring programming accuracy, traceability, and compliance with internal processes and regulatory expectations
+ Develop and support programming outputs across a wide range of data types, including exploratory biomarker data and real-world data
+ Collaborate on Exploratory Data Analyses (EDAs), enabling insight generation to inform drug development strategies and enhance scientific communication
**Qualifications:**
+ Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field
+ A minimum of 3 years of experience in statistical programming in a clinical development setting supporting Oncology trials/research, or an advanced degree with 1-3 years of equivalent work experience
+ Proficient in and have recent working knowledge of SAS and R
+ Basic understanding of statistical quality, endpoints, and QC processes
+ Experience with Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., SDTM and ADaM)
+ Demonstrated ability to deliver programming outputs independently
+ Fluent in English
**Preferred Qualifications:**
+ Demonstrate critical thinking, strong organizational and problem-solving skills
+ Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences
+ Experience with drug development (early and/or late stage)
+ Oncology experience is highly desired
+ Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders
\#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.
$85k-112k yearly est. 6d ago
Senior Medical Writer- FSP
Parexel 4.5
Annapolis, MD job
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.
$85k-124k yearly est. 34d ago
Cagewash Attendant I (14BS)
Charles River Laboratories 4.3
Charles River Laboratories job in Bethesda, MD
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 Attendant I to join our Insourcing Solutions team located in Bethesda, MD.
As the Cagewash Attendant I, you will sanitize, maintain and repair animal cagewash materials.
Additional responsibilities include:
+ Follow SOPs and quality assurance standards
+ Perform routine preventative maintenance on cagewash and autoclaves
+ Maintain animal holding facilities clean and organized
+ Other tasks may include assist with receipt, stocking and maintenance of inventory supplies
+ Become involved in animal care and husbandry of multiple animal species
**Job Qualifications**
The following are minimum requirements related to the Cagewash Attendant I position:
+ High school diploma or GED preferred
+ Knowledge of detergent/disinfectant and operating knowledge of sanitization and sterilization equipment
+ Cagewash experience preferred
+ Must be successful in obtaining the ALAT (Assistant Lab Animal Technician) Certification within 1 year of eligibility.
The pay for this position is $18.50 USD per hour. Schedule: Monday through Friday 7AM-3:30PM.
**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 ***************
231674
$18.5 hourly Easy Apply 12d ago
Investigator Financial Analyst II
Parexel 4.5
Annapolis, MD job
Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. **Job Title** : Investigator Financial Analyst II **Job Introduction** : At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an **Investigator Financial Analyst** **II** to join our team. As an Investigator Financial Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by steering the investigator budget management for crucial projects. Through the collaboration and diversity of the Investigator Payment Division the Investigator Financial Analyst is provided with opportunities to excel and discover where your skills can take you.
**Who we are looking for** :
Curious individuals interested in understanding investigator budget economic drivers. Who are detailed-oriented while assisting in translating the clinical conduct into a financial impact and proactively advising the project leader and the project financial analyst on how to influence critical budget and cash flow levers to prevent negative impact project financials.
**What you'll do** :
+ Lead the monthly investigator payment forecast cycle and support project analysis requirements, including a review of accruals, costs incurred, contracts signed, and patients enrolled.
+ Collaborate with clients, clinical team members, and other members of the organization to gather information and/or explain the financial impact of the observed clinical conduct.
+ Manage all required variance analyses for the set of projects, with insight and identify risks in the project forecast and to the budget.
+ Present updates on financial status of investigator payments for assigned projects and create information in response to client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio.
**Why join us:**
Be part of groundbreaking projects that are pushing the boundaries of the industry.
Experience a collaborative and inclusive work environment that highly appreciates your expertise.
Unlock your full potential with professional growth and development opportunities.
Enjoy work life balance and flexible working hours.
**Parexel US Benefits** :
+ Health, Vision & Dental Insurance
+ Tuition Reimbursement
+ Vacation/Holiday/Sick Time
+ Flexible Spending & Health Savings Accounts
+ Work/Life Balance
+ 401(k) with Company match
+ Pet Insurance
Full list of benefits available here: ***********************************
**About Parexel International:**
At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors.
If this job does not sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
\#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.
$80k-131k yearly est. 8d ago
Technical Supervisor (14DNR)
Charles River Laboratories 4.3
Charles River Laboratories job in Bethesda, MD
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 Technical Supervisor to join our Insourcing Solutions Team located in Bethesda, MD.
As the Technical Supervisor, you will provide oversight and leadership to the LATs and Breeder Technicians. A key duty of this position is scheduling and assigning technical service requests.
Additional responsibilities include:
* Addressing customer requests, inquiries, and concerns.
* Performing quality assurance of animal health records and logs, and procedure rooms.
* Assessing staff performance and assisting with technical training needs.
* Providing animal treatments and assisting with rodent colony health surveillance program and submission.
* Assisting with covering technical support and duties to include animal handling and restraint, weaning, tail snips, ear tagging, collect blood/tissue samples, perform injections, irradiations, treatments, surgical preparation and post-operative observations, timed mating, microinjections, and assisting with research procedures as directed.
* Familiarity with and ability to apply/use various forms of anesthesia.
* Attending pre-study meetings and providing insight to relatable researcher support and needs.
* Maintaining and archiving various logs.
* Assisting with coverage of other areas of facility as needed.
**Job Qualifications**
The following are minimum requirements for the Technical Supervisor:
* High school diploma or GED required.
* At least 3 years related to animal care and handling experience performing laboratory animal technician duties, with at least 1 year in a supervisory/leadership capacity.
* Laboratory Animal Technician (LAT) certification required.
The pay range for this position is $34 to $37 USD per hour. The schedule is Monday through Friday 7AM-3:30PM, must be available to work some holidays and weekends when necessary.
**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 ***************
231723
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Baltimore, MD Derm2_156304
Company overview:
For more than a century, we have stayed true to a core set of values-excellence, integrity, and respect for people-that guide us in all we do. We also are committed to investing in our employees and supporting a culture of well-being -through competitive pay, comprehensive employee benefit programs, and training and development resources. #WeAreLilly
Sound interesting to you? Read on to find out more about how you can join our sales team, where you will enjoy meaningful work, build a successful career and make important contributions to our patients' lives.
Lilly is committed to helping people suffering from Autoimmune diseases. Our mission is to make life better for people around the world living with debilitating immune-mediated diseases in dermatology and rheumatology. That means raising the bar for treatment expectations in the field of immunology, as we develop and launch innovative treatment solutions that may reduce the burden of diseases such as psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylarthritis and alopecia areata.
Together we embrace the challenge to redefine what's possible.
The Lilly Dermatology Specialty Territory Managers will be responsible for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly dermatology portfolio. This includes HCPs in dedicated dermatology practices, as well as representatives in key hospital accounts, including dermatologists, dermatology fellows, dermatology educators, chief internal medicine residents, chief family practice residents and residents involved in dermatology rotations. You will build relationships with key customers in the dermatology space to increase Lilly's ability to drive adoption of our new and existing therapies. They will also identify and develop business relationships with state and local advocacy groups, teaching institutions, key influencers, and managed care organizations. They will be viewed as a credible expert and resource.
BUSINESS OWNERSHIP
Territory Management
Develops a strong understanding of territory and reimbursement landscape and utilizes appropriate business insights tools to analyze and adapt to business needs.
Account Management
Systematically navigates the ever-changing healthcare environment to understand accounts and impact key stakeholders to become a trusted partner.
SELLING SKILLS / CUSTOMER EXPERIENCE
Dialogue Agility
Actively listens and adapts to verbal and non-verbal customer prompts throughout the call.
Medical Integrity
Demonstrates high learning agility to understand clinical information / disease state, our product portfolio, and the therapeutic marketplace.
Uses this information to engage with every member of an office / account.
Selling Skills
Promotes the entire product portfolio by planning for and engaging in a patient centered dialogue with customers.
Utilizes our selling model prior to and during conversations with customers to help them identify appropriate patients.
EXECUTION / RESULTS
Sales Activity
Utilizes all business analytic resources available to meet the needs of customers and achieve sales goals while acting in a manner consistent with all internal policies and procedures and PhRMA code.
Partner Collaboration
Collaborate effectively with others, both field-facing and internal peers to create a coordinated and positive customer experience.
BASIC QUALIFICATIONS:
Bachelor's degree.
Professional certification or license required to perform in this position if required by a specific state.
Valid US driver's license and acceptable driving record is required.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
Additional skills/preferences:
Two or more years of sales experience (pharmaceutical or non-pharmaceutical) after completion of an undergraduate college degree.
Other work experience following the completion of undergraduate degree, or a graduate degree (e.g., Masters, MBA, PharmD).
Demonstrated business ownership skills, selling/customer experience skills, and execution/results.
Account-based selling experience. Ability to identify and engage staff members in accounts.
Strong background in navigating within complex integrated health systems.
Extensive experience or thorough understanding of specialty pharmacy distribution model.
Selling injectable/infusion molecules in a complex reimbursement environment.
History of working with multiple cross functional partners.
Strong Learning agility, self-motivated, team focused, emotionally intelligent and influential.
Must live within 30 miles of the territory boundary.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$87,000 - $159,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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.
$88k-127k yearly est. 60d+ ago
Repository Specialist I (Sample Management Associate)
Charles River Laboratories 4.3
Charles River Laboratories job in Frederick, MD
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 **Repository Specialist** for our **Insourcing Solutions** team based at our facility in **Frederick, MD** .
As the **Repository Specialist** , you will receive, handle and inventory specimens of human, animal and/or plant origin at temperatures ranging from ambient to -195°C, as well as weigh and prepare samples for pickup, courier delivery and shipment. Additionally, you will be tasked with maintaining repository files for validation of data and preparation of reports, as well as review accumulated data for accuracy and prepare reports of information and sample data.
Additional responsibilities include:
+ Assemble and display data for the storage and retrieval of specimens and for report preparation.
+ Perform freezer inventories, as well as operate and freeze specimens utilizing controlled-rate freeze equipment.
+ Participate in temperature/liquid nitrogen (LN2) liquid level monitoring and emergency response rotations.
+ Process and aliquot specimens.
+ Enter data into client's online repository database for sample tracking and inventory management.
+ Driving client vehicle to deliver and pick-up specimens locally.
**Job Qualifications**
The following are minimum requirements related to the **Repository Specialist** position:
+ High School Diploma or equivalent
+ Valid driver's license
+ A minimum of two years related office and administrative experience preferred
+ Experience working in a shipping/receiving environment with scientific data preferred
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
The pay for this position is $20.00 per hour.
**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 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 ***************
231136
$20 hourly Easy Apply 58d ago
Inside Sales - Market Development Analyst
Parexel 4.5
Annapolis, MD job
Join Parexel's team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. **Job Title:** Market Development Analyst At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking a Market Development Analyst to join our team. As a Market Development Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences for patients by connecting new clients with Parexel's capabilities. Through the collaboration, and diversity, of teams the Market Data Analyst is provided with multiple opportunities to excel and discover where your skills can take you.
**Who we're looking for:**
+ Excellent communicator to effectively present information and respond to questions from groups of managers, clients, customers, and other business units
+ Analytical mind to read and interpret general business periodicals, professional journals, and technical procedures
+ Strong interpersonal skills with the ability to establish and maintain effective working relationships
+ Quick learner who excels in a rapidly changing environment
+ Practical problem solver
+ Minimum 2 years' experience in B2B lead generation or sales role
**What you'll do:**
+ Work strategically with Marketing and Sales Teams to generate marketing campaigns for all lines of the Parexel business including promoting webinars, customer days and other marketing-driven events.
+ Analyze potential opportunities and develop strategies to support increasing client awareness and engagement; monitor actions and results against plans
+ Schedule introductory business development calls between sales team members and target company decision-makers.
+ Work closely with Sales Associates and Account Executives to ensure smooth transfer of information and accounts.
+ Collaborate with Director of Market Development, senior Sales staff, and Subject Matter Experts to develop market strategies to generate leads with new clients; re-engage past clients, and within current core accounts across all Parexel service lines.
+ Respond to Parexel web leads / inbound requests as first point of contact to conduct needs assessment
+ Track all activity with prospects and clients in Parexel's CRM system
+ Other responsibilities as assigned
**Additional details:**
+ Prior CRO, life sciences, or consulting company experience preferred but not required
**Why join us:**
+ Be part of groundbreaking projects that are pushing the boundaries of the industry.
+ Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities.
+ Enjoy work life balance and flexible working hours.
**Parexel US Benefits:**
+ Health, Vision & Dental Insurance
+ Tuition Reimbursement
+ Vacation/Holiday/Sick Time
+ Flexible Spending & Health Savings Accounts
+ Work/Life Balance
+ 401(k) with Company match
+ Pet Insurance
+ Full list of benefits available here: ***********************************
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors.
\#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.
$89k-121k yearly est. 26d ago
Research Support Specialist I - Vet Techs encouraged to apply
Charles River Laboratories 4.3
Charles River Laboratories job in Poolesville, MD
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 Support Specialist I for our Insourcing Solutions site located in Poolesville, MD.
+ Prepare and administer research treatments; collect and record physiological data (weight, temperature, pulse, respiration)
+ Perform technical procedures as needed associated with the Animal Study Proposals in relation to NHP retroviral, human respiratory and flavivirus studies to include but not limited to blood collection, IV catheterization, intubation, broncho-alveolar lavage, tracheal and nasal lavages, documented research observations, and administration of research treatments
+ Must have a basic understanding of aseptic technique, anesthesia induction, monitoring, and recovery as well as drug dosage calculations and administration
+ Assist Veterinarian & Sr. RSS staff with surgeries and specialized procedures
+ Perform daily animal health observations and report any abnormal findings to veterinarian
+ Maintain electronic medical records, send daily emails regarding animal health information to vet staff
+ Collect, preserve, and prepare blood, urine, stool, and tissue samples
+ Participate in study related necropsies/tissue harvest
+ Set-up for procedures and prepare supplies and equipment
+ Ability to maintain freezer organization and sample inventory
+ Practice universal precautions appropriate to different levels of ABSL. Work safely with animal / human pathogen biohazards and help to maintain the research animal facility as a safe work environment / operation
+ Report any animal health, care, and / or wellbeing concerns to the appropriate facility management staff
+ Report any facility infrastructure issues, relative to the animal care and support areas to the appropriate facility management
**Job Qualifications**
The following are the minimum requirements related to Research Support Specialist I:
- High school diploma or general education degree (GED) required. BS degree in Animal Science, Biology, or similar discipline, or A.A. in Veterinary Technology is preferred.
- 2-3 years' experience working with non-human primates in biomedical research or 2-3 years Veterinary Hospital technical experience preferred.
- Must have computer program proficiency such as MS Word / Access / Excel. Must have a proficient technical vocabulary.
- RVT/CVT/LVT or LAT certification preferred
The hourly range for this position is between $28/hour and $30/hour. Please note that salaries vary within the range based on factors including, but not limited to skills, certifications and locations.
**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 ***************
231066
$28-30 hourly Easy Apply 60d+ ago
Laboratory Technician (Per Diem - Day Shift)
Parexel International 4.5
Baltimore, MD job
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Title: Laboratory Technician - Day Shift (Per Diem)
Work Location: onsite Baltimore, MD
Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans.
Your time here: as a Laboratory Technician you will have a thorough understanding of study protocols and lab manuals, utilize various processing laboratory equipment and will perform various diagnostic laboratory tests. Additionally, Laboratory Technicians ensure sample processing is completed correctly, monitor the laboratory and supplies needed as well as drive efficiency and accountability within the unit.
Starting your journey with Parexel comes along with an extensive induction program and ongoing training while following your individual career path.
What you'll do after training is completed (including but not limited):
Collect (as appropriate), process and store human biological specimens according to protocol.
Perform standard diagnostic laboratory tests (for example pregnancy tests, urinalysis, and drugs of abuse tests).
Prepare and organize laboratory equipment and facilities, documentation and schedules for studies.
Identify and problem solve study-related issues as they arise, bringing it to the attention of the correct supervisor.
Maintain a positive, results orientated work environment, building relationships with management, colleagues, and other departments, communicating in an open, balanced and objective manner.
Your Skills:
Experience working in a lab either in a professional setting or through university courses.
B.S./M.A.+ in related life science field or HS Diploma with experience
Commutable distance to the unit located in Baltimore, MD
Understanding of laboratory procedures and best practices.
Customer service experience in a fast-paced environment
Hours/Shift - all shifts are onsite (no remote work)
Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training during the day. Shifts are typically 6:50am to 3:20pm
After training is completed:
Minimum Availability requirements: 16 hours of availability a week (including 1 weekend shift)
Shift Details: We are looking for adaptable candidates who primarily work the day shift 6:50am to 3:20pm during the week as well as weekend
The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed)
Base Pay Range: $18.00 to $22.00 per hour
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives.
Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.
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.
$18-22 hourly Auto-Apply 39d ago
Quality Control Coordinator I
Charles River Laboratories 4.3
Charles River Laboratories job in Rockville, MD
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 Quality Control (QC) Coordinator is a key administrative and logistical support role within the Quality Control department, ensuring the efficient and compliant management of all product samples and associated data. This position serves as the central point of coordination for sample lifecycle activities, from receipt and inventory management to data archiving and external shipment, while strictly adhering to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). The coordinator works cross-functionally with Project Managers (PMs), laboratory personnel, and external testing sites to maintain data integrity and operational efficiency.
Key Responsibilities and Duties:
+ Coordinate the receipt, logging, labeling, storage, tracking, and disposal of all QC samples.
+ Maintain accurate inventory records of all retain, stability, and release samples using LIMS or designated tracking systems.
+ Prepare documentation (sample submission forms, shipping request forms, etc.) and coordinate compliant shipment of samples to clients and external testing sites.
+ Manage the process for pulling stability samples at specified time points for testing initiation.
+ Systematically retrieve, archive, and track QC data packages, ensuring secure storage and accessibility.
+ Collaborate with departments to perform audit trail reviews on electronic instrument reports and raw data to ensure data integrity and 21 CFR Part 11 compliance.
+ Maintain and update trackers, logbooks, and databases reflecting current sample and testing statuses.
+ Serve as the liaison for sample data requests, collaborating with Project Managers and other stakeholders.
+ Provide administrative and logistical support to the Quality Control department and management team for ad-hoc projects and general coordination tasks as required.
**Job Qualifications**
+ High school diploma or equivalent is required. An Associate or Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Life Sciences) or relevant higher education is strongly preferred.
+ 1-3 years' experience in a GMP/GLP environment (QC or sample management preferred)
+ Proficiency in LIMS, EDMS, and MS Office Suite (Excel, Word) preferred
+ Exceptional attention to detail and strong organizational skills.
+ Excellent communication skills for effective internal and external collaboration.
+ Ability to manage multiple priorities in a fast-paced environment.
Compensation Data
The pay rate for this role is $24.00 - $26.00 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 Charles River's CDMO Services
With over 20 years of experience and industry-leading expertise, Charles River's cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities-including plasmid DNA, viral vector, and cell therapy manufacturing-enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
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 ***************
231565
$24-26 hourly Easy Apply 30d ago
Primate Technician I
Charles River Laboratories 4.3
Charles River Laboratories job in Frederick, MD
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.
**IMPORTANT:** In order to be considered for this position, **a resume/CV must be uploaded and submitted during the application process.** Please make sure work history and education are added correctly.
**Job Summary**
This is an entry-level position where you can gain experience and begin your career in life sciences. Training provided!
As a Primate Technician I, you will be responsible for the daily care of research animals. Your contribution will ensure the health and well-being of our animals, as well as impact the lives of patients across the world.
Work schedule: Friday - Monday, 5:00am - 3:00pm (4x10) or Sunday - Thursday, 6:00am - 2:30pm
Responsibilities:
+ Providing food and water
+ Inspect feeding and watering devices for proper function
+ Cleaning and sanitizing cages and enclosures
+ Observe animals for overall health and wellbeing
+ Assisting with the movement of animals
+ Log animal care data and maintain accurate records
+ Other assigned duties, including restocking supplies
Work Environment & Physical Demands:
+ Work is performed in an _warm,_ climate controlledenvironment.
+ PPE (protective equipment) includes regular use of surgical mask, cap, goggles, face shield, scrubs, and boots.
+ The warm setting, physicality of the job duties, and use of personal protective equipment (PPE), when combined, frequently cause employees to become hot and sweaty.
+ Job duties require employee to regularly stoop, crouch, kneel, and reach up with hands and arms to perform repetitive tasks, and walk and stand for extended periods of time.
+ Employee must be able to regularly lift, hold and/or move up to 50 pounds.
**Job Qualifications**
_If you possess the following qualities, we will train you in the rest:_
+ High School Diploma or GED _preferred_ , but not required
+ Animal care experience _preferred_
+ Previous experience in a physically demanding role
+ Previous experience maintaining records and complying with regulations and Standard Operating Procedures (SOPs)
+ Strong attention to detail
+ Enjoys being part of a team
+ Flexible and available to work holidays (on rotational basis) and overtime as needed
The starting pay for this position is $19.75 per hour.
**IMPORTANT: A resume is required to be considered for this position.** If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
**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 120 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 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 ***************
230980
$19.8 hourly Easy Apply 49d ago
Associate Director Quality
Charles River Laboratories 4.3
Charles River Laboratories job in Rockville, MD
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 Associate Director Quality is responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations, functional support organizations, and execution of GMP activities at the Rockville site. The candidate filling this role is responsible to oversee execution and delivery from the following areas of the organization: Functional Organization Quality Oversight, On the Floor Quality as well as customer facing Quality program leads for each client in the CDMO-Rockville portfolio. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cell-based gene therapy production.
Key Responsibilities and Duties:
+ Monitors projects and help to resolve issues or escalate appropriately to ensure on time delivery of all client projects with management of effective risk mitigation plans and stakeholder communication
+ Collaborates with full range of personnel in manufacturing and technical work teams that support Fill/Finish to identify root cause of a problem and determine appropriate corrective action and preventive action for investigations
+ Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports, prepare BPR audit reports and follow-up with task owners for the completion of the identified deficiencies
+ Ensures that QA batch record review and lot release deliverables are client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements
+ Responsible for lot disposition and release of products
+ Reviews and approves batch production and development records in support of GMP regulated operations
+ Reviews and approves ancillary facility and equipment records in support of GMP regulated operations
+ Reviews and approves assay qualification, equipment, and stability protocols and reports
+ Provides technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Contributes to data and information collection
+ Alerts management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions
+ Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedure
+ Oversees the revision, issuance and tracking of controlled documents used to support the bulk and sterile fill biologic products
+ Drives continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
+ Actively participates in all recruiting efforts to secure, onboard, and develop new staff members
+ Perform Quality Control data and audit trail review
+ Additional duties as assigned, including a willingness to cross-train and support in other functional Quality areas such as Quality Systems, Training, Document Control, and Supplier Quality
**Job Qualifications**
+ BS/BA required; MS preferred in scientific/technical discipline
+ Minimum of 8 years of experience in a Quality department leadership role within the biological and/or pharmaceutical industry
+ Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
+ Experience in reviewing quality control test reports and batch production records clinical and commercial pharmaceutical/ biopharmaceutical manufacturing
+ Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines
+ Experience in TrackWise is preferrable
+ Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
+ Exceptional verbal and written communication skills to all organization levels and clients
+ Strong organizational skills; able to prioritize and manage through complex processes/projects
+ Ability to define problems, collect data, and draw valid conclusions.
+ Extensive experience with writing and managing investigations and risk assessments
+ Previous experience as an auditor for internal and vendor audits
+ Ability to be hands-on and detail oriented
Compensation Data
The pay rate for this role is $156,000 - $176,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Charles River's CDMO Services
With over 20 years of experience and industry-leading expertise, Charles River's cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities-including plasmid DNA, viral vector, and cell therapy manufacturing-enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
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 ***************
231701
$156k-176k yearly Easy Apply 7d ago
Clinical Research Nurse (RN) - Per Diem
Parexel International 4.5
Baltimore, MD job
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans.
At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing.
Develop professionally by gaining experience in delivering high-quality research projects in this growing sector.
What you'll do after training is completed (including but not limited):
Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).
Assume responsibility for patient care and study conduct assignments.
Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed.
Ensure that all established timelines relating to areas of responsibility and assigned projects are met.
Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.
Assess, monitor, record, and report patient's condition and reaction to drugs and treatments to the appropriate physician.
Collect and prepare data. Organize and enter data into case report forms.
Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File.
Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.
Act as participant advocate in the conduct of clinical studies.
Qualifications
At least 2 years working in a hospital or clinical setting
BSN preferred or relevant work experience.
Active Registered Nurse License in the state of Maryland
Current Basic Life Support (BLS) certification.
ACLS certification required within 6 months of start date
Base Pay Range: $40.00 to $45.00 per hour
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.
Parexel is dedicated to supporting, developing and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers here at Parexel. The following military career roles align with this position 66G, 66H, 68C, 4NOX1, 46NX, 66S, 66T, 290X.
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.
$40-45 hourly Auto-Apply 17d ago
Animal Care Technician II
Charles River Laboratories 4.3
Charles River Laboratories job in Baltimore, MD
For 70 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 Animal Care Technican II for our Insourcing Solutions site located in Baltimore Maryland.
The following are responsibilities related to the Animal Care Technican II.
* Performs animal husbandry duties including but not limited to preparation and actual changing of animal cages and related cage accessories of small and large animals, feeding and manual watering or monitoring/ testing automatic watering devices under minimal supervision.
* Performs cage wash duties as needed. Prepares caging for cagewash, including scraping floor grids, breaking down caging and dumping pans or scraping cages.
* Trains and mentors staff when requested.
* Performs daily animal health observations and reports any abnormal conditions or behavior of animals to the Immediate Supervisor, Facility Manager, Veterinary Technician, and/or Clinical Veterinarian.
* Cleans assigned animal rooms, facility and animal care equipment and associated animal facility areas as assigned.
* Obtain weekly animal census.
* Monitors and reports any irregularities in the room temperature, light cycles, air changes, and other environmental conditions that may affect animals.
* Ensures that all logbooks, checklists and other records are completed accurately in a timely fashion.
* Provide environmental enrichment feed and other enrichment stimuli and/ or provide behavioral assessments.
* Provides lead role on assigned weekends/holidays.
* Performs all work assignments in accordance with guidelines established by federal, state, and local regulatory agencies and NIDA SOP and specific protocol instructions.
* Performs euthanasia using correct procedures.
* Provides a regular and predictable attendance schedule.
Job Qualifications:
* High school diploma or General Education Degree (G.E.D.)
* 2 -3 years related experience in animal care with at least one year of that time working with laboratory animal species, most applicable rodents and non-human primates preferred.
* ALAT certification required
The hourly pay for this position is $24/hour.
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 14,000 employees within 80 facilities in 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. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
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 ~85% of the drugs approved by the FDA in 2018.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet
229788