Kristine Nadeau
Rolesville, NC
Summary
Experienced biotechnology and pharmaceutical professional with expertise in drug development and safety assessment. Recognized for reliability and delivering high-quality results in dynamic team environments. Skilled in verifying scientific data, ensuring accurate documentation, writing scientific reports, and creating transgenic models. Collaborative and adaptable work ethic. Seeking new opportunities to contribute and advance in the field.
Overview
25
25
years of professional experience
Work History
Research Associate III
Charles River Laboratories
09.2017 - Current
- Company Overview: Pathology Associates/Safety Assessment
- Provide Study Coordination, Scientific Coordination, Publishing support, Data Provide input to pathologists on workload prioritization (Anatomic and Clinical Pathology)
- Review study file for accuracy of scope of work prior to study initiation
- Assist pathologists with client communication, project tracking, and coordination
- Monitor key study events including deliverables to client
- Prepare tables, narrative, and images for pathology reports
- Provide quality control review of various types of toxicology anatomic pathology/histopathology reports (Neuropathology, Inhalation, Carcinogen and Reproductive to name a few specialties) and corresponding data
- Experience with both Anatomic and Clinical Pathology report writing
- Work with Regulatory Affairs and Compliance and the various laboratories to respond to audits
- Coordinate the statistical analysis of data as needed
- Produce individual and summary data for report appendices, tables, and graphs, customize as necessary to meet client specific reporting requirements
- Liaise with all departments to negotiate and propose schedules based on various study designs
- Compilation of anatomic or clinical pathology reports according to report schedule
- Assist with management of QA audits, assure necessary corrections and follow-up take place
- Assist in documentation of study deviations from study protocol or Standard Operating Procedures (SOP)
- Interact with Study Directors: send regulatory forms for signature, respond to requests for information on tables, and assist with on-site Peer Review visits
- Run tables for pathologist and for pathology report using WTDMS and Provantis
- Member of the Scientific Efficiency Team, CRAM [Cost Recovery Action Meeting [recovered amount to date ~$21K in 3 years)], RML (Resource Management Lead) and various other teams
- Aide in interviewing, training, and mentoring of potential candidates
- Perform all other related duties for Study Coordination, Scientific Coordination, Publisher, Scheduler, Data Coordination, and Research Associate as assigned
- Pathology Associates/Safety Assessment
Project Manager II
Charles River Laboratories
06.2012 - 08.2017
- Company Overview: Genetically Engineered Models and Services/Research Models Services
- Develop and implement project plans for routine to complex projects, including project initiation activities, communications and cost estimates
- Manage routine to complex GEMS client colonies; actively monitor quality of activities, operations and/or projects and make day-to-day decisions
- Perform continuous review of projects
- Communicate financial impact based on customer plans for strategic planning
- Serve as primary contact for many top clients and provide and coordinate needs of Principle Investigators, project updates to client and manage project goals/expectations
- Develop in-depth client relationships and serve as internal liaison for the organization's services
- Develop an understanding of client's business needs and offer service solutions related to the complexity of the projects being managed
- Resolve routine complex requests, inquires and complaints and provide technical assistance to existing customers
- Develop solutions and make recommendations to remove any roadblocks that would prevent a goal and or expectation to be met
- Ensure timely and communication regarding project initiatives and milestones through the life of the project
- Ensure colony health reports are reviewed and distributed
- Coordinate invoicing process including credits, rebills and support accounting in collecting delinquent accounts
- Provide mentoring and training for departmental staff on new or revised SOP's
- Collaborate with Project Management, Scientific and Veterinary staff to address client requests
- Work closely with the legal department on draft agreements to facilitate execution of Master Service Agreements
- Ensure work is performed in compliance with Sarbanes-Oxley and other applicable regulations
- Perform all other related duties as assigned
- Genetically Engineered Models and Services/Research Models Services
Supervisor, Technical Services
Charles River Laboratories
01.2011 - 09.2012
- Company Overview: Genetically Engineered Models and Services/Research Models Services
- Oversee daily operational activities and supervise a group of non-exempt employees
- Ensure optimum group performance
- Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews
- Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans
- Support the policy of equal employment opportunity through affirmative action in personnel actions
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]
- Support the customer service department and ensure excellent service to our clients
- Continue to do all duties of Administrator (see below)
- Perform all other related duties as assigned
- Genetically Engineered Models and Services/Research Models Services
Associate Supervisor, Technical Services
Charles River Laboratories
01.2009 - 01.2011
- Company Overview: Genetically Engineered Models and Services/Research Models Services
- Give direct support to Manager and assist in all Supervisory activities
- Oversee daily operational activities and supervise a group of non-exempt employees
- Ensure optimum group performance
- Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews
- Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans
- Support the policy of equal employment opportunity through affirmative action in personnel actions
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]
- Support the customer service department and ensure excellent service to our clients
- Continue to do all duties of Administrator (see below)
- Perform all other related duties as assigned
- Genetically Engineered Models and Services/Research Models Services
Administrator, Technical Services
Charles River Laboratories
01.2004 - 01.2009
- Company Overview: Genetically Engineered Models and Services
- Provide external clients with necessary information to effectively manage their colonies
- Participate in training of new employees and in delegating the heavy workload
- Work with the Product Management department to provide external customers with monthly billing statements
- Provide upper management and with quarterly Royalty report
- Coordinate multiple technicians, as well as, other members of GEMS, in the task of weekly biopsy submissions for a demanding customer
- Use my past many years animal care experience and B.S
- Degree to work closely and efficiently with Project Managers, Vet Staff, technicians and others within the TGS community
- Help the technicians on the floor watering and feeding to ease the workload during a time of need
- Take large part in training of new/current GEMS staff in my areas of my expertise (genetics or skills that I have previously mastered, etc.)
- Willing to help others achieve goals and do so in a non-discriminating way
- Understanding fully that not all people within GEMS possess the same knowledge of the same things
- Adjust project information to meet the special needs of customers (mating tables, spreadsheets, databases, etc.)
- Genetically Engineered Models and Services
Record Coordinator, Technical Services
Charles River Laboratories
09.2001 - 01.2004
- Company Overview: Genetically Engineered Models and Services
- Provide external clients with necessary information to effectively manage their colonies
- Use my past many years animal care experience and B.S
- Degree to work closely and efficiently with Project Managers, Vet Staff, technicians and others within the TGS community
- Help the technicians on the floor watering and feeding to ease the workload during a time of need
- Adjust project information to meet the special needs of customers (mating tables, spreadsheets, databases, etc.)
- Genetically Engineered Models and Services
Animal Technician II/III
Harvard Medical
12.2000 - 09.2001
- Maintained health of mouse colonies by following AALAC and USDA protocol
- Responsible for overall care of multiple colonies including: feeding, watering, euthanization, cage changing, weaning, sterilization, etc
- Observed a variety of strains of rodents and recognizing abnormal change
- Worked closely with the investigators to insure proper SOP's were followed
- Responsible for training new employees and taking inventory of present and newly arrived animals
- Worked with non-human primates, where my duties we the same as performed on rodents (with exception of euthanization and weaning)
Zookeeper Intern/Researcher/Seasonal Keeper
Zoo New England
05.2000 - 12.2000
- Conducted two research projects
- Designed and constructed a squirrel maze to obtain data from 1999 breeding season to study parental investment in Phoenicopterus chilensis and Phoenicopterus ruber in captivity
- After interning as a zookeeper, hired as a seasonal keeper
- Cared for diverse collection of mammals, birds and reptiles
- Duties included feeding, medicating, providing daily enrichment, daily observation, and daily records
- Assisted in animal restraint and veterinary procedures
Education
Bachelor of Science - Biology
Framingham State College
Framingham, MA01.2000
High School Diploma -
Wilmington High School
Wilmington, MA01.1994
Skills
- Scientific and Technical Report Writing (Anatomic and Clinical Pathology, Immunohistochemistry, Electron Microscopy and Specialty Pathology)
- Provantis (GLP-compliant preclinical study management software)
- MFiles and SDMS (document management platforms)
- Microsoft Office (Excel, word, etc)
- Workbook and DocuSign
- RPM-Report Progress Monitoring
- SAP (Systems, Applications, and Products in Data Processing)
- Strong multitasking and Highly reliable
- Customer relationship management (CRM)
- Sales support (invoicing for scientific projects)
- Research ethics and Workplace safety
- Data interpretation
- Workforce management
- Research and analysis
- ICM -Internet Colony Management (rodents breeding)
- Animal Nutrition, Capture and Restraint
- Behavioral Conditioning and Enrichment
- Research and Exhibit Engineering
- Training and mentoring
- Project planning, Development and Execution
- Scheduling coordination
- Data entry and QC
Certificates And Training
- LAT certified
- Lean Sigma White Belt Training
- Leadership Workshop
- Management Skills
- Leadership and Mentor Award
Languages
English
Full Professional
Timeline
Research Associate III
Charles River Laboratories
09.2017 - Current
Project Manager II
Charles River Laboratories
06.2012 - 08.2017
Supervisor, Technical Services
Charles River Laboratories
01.2011 - 09.2012
Associate Supervisor, Technical Services
Charles River Laboratories
01.2009 - 01.2011
Administrator, Technical Services
Charles River Laboratories
01.2004 - 01.2009
Record Coordinator, Technical Services
Charles River Laboratories
09.2001 - 01.2004
Animal Technician II/III
Harvard Medical
12.2000 - 09.2001
Zookeeper Intern/Researcher/Seasonal Keeper
Zoo New England
05.2000 - 12.2000
High School Diploma -
Wilmington High School
Bachelor of Science - Biology
Framingham State College
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