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Positions Available
The following positions are available at SNBL USA in Everett, WA (unless otherwise noted). To apply for an open position, submit your cover letter and resume to: hr@snblusa.com. Due to the high volume of resumes received, please note only applicants that are being considered for the respective position(s) will be contacted. Thank you for your interest in SNBL USA.
Laboratory Services Director
The Director of Laboratory Services will be responsible for directing the Laboratory Services organization by providing administrative and scientific leadership to ensure the attainment of operational goals and participate with the executive management team in formulating current and long-range plans, objective and policies.
Responsibilities:
- Monitor level of GLP compliance, study schedules, review and monitor study organization, process improvement and adherence to SOPs
- Assure the development, review, revision and implementation of SOPs, SSPs, Policies, Training Manuals and/or Checklists relating to technical procedures, facility issues, and date generation
- Assign Study Staff as appropriate to meet study objectives
- Designates Study Director, Principal Scientist, Contributing Scientist, and Principal Investigator to meet study objectives
- Direct and manage departmental resources, personnel and fiscal assignments and allocations
- Act as company representative to outside agencies, including; FDA, and local regulatory agencies
- Contribute to the resolution of quality assurance issues
- Manage and ensure departmental Directors, Managers and Supervisors are compliant with corporate directives
- Confer with scientists regarding research, and reviews technical papers and reports
- Attend planning meetings as well as develops and expands laboratory analytical capabilities
- Identify and implement techniques and instrumentation to increase efficiency in sample preparation, handling and analysis and strategically position the department for high throughput (from automated instrumentations (96-well plate liquid handling to analysis), to LIMS (data capturing), to output (efficient reporting of data) analysis
- Administrate instrumentation and software qualification and validation
- Represent Laboratory Services interests on IT hardware/software teams (eg, LIMS)
- Monitor the quality of data entered and calculated by the departments
- Review and assign staff; manage reporting structure
- Stay informed on current scientific and regulatory issues by reviewing scientific literature and attending scientific meetings
- Travel to client and professional meetings to present scientific papers and capabilities of SNBL USA's Laboratory Services program(s)
- Replace the Principal Scientist, Contributing Scientist and Principal Investigator promptly if it becomes necessary to do so during the conduct of a study
Requirements:
- Master's degree in chemistry or biology and 7-10 years experience in analytical or preclinical, or a PhD in chemistry with at least 5 years experience in analytical or preclinical or equivalent training and experience, specializing in formulations
- Experience in an FDA or EPA regulated environment preferred
- 3+ years of supervisory experience
Comprehensive benefits package and relocation assistance is included. Apply for this position by submitting your cover letter, CV, and salary requirements to: hr@snblusa.com.
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Project Coordinator
The Project Coordinator will be responsible for the life-cycle of assigned preclinical SNBL USA projects including: generating schedules and cost estimates for inquiries and tracking study progress through finalization. This position works in conjunction with the Study Directors to act as Project Coordinator for confirmed studies (projects). This position will work cross functionally with many departments across SNBL USA (ie, Client Services, Contracts, Estimates, Study Directors and Scientific Services) to ensure project success.
Responsibilities:
- Generate study schedules for new inquiries
- Maintain Good Laboratory Practices (GLP)
- Track compliance and report status to management team
- Schedule resources, generate final timeline and coordinate with affected departments that resources are available once project agreement is confirmed
- Negotiate timeline deliverables/start dates with client in conjunction with Account Managers to ensure realistic deadlines
- Track all changes of project from initial contract through final report
- Monitor changes to project during the study: communicate any delays to ensure affected departments have been notified and continue to follow-up on project status as needed
- Communicate any changes to responsible teams; ensure resource/time, etc is acceptable
- Ensure all client delivery dates and milestones are met and communicate any delays to Study Director and Senior Management
- Review all studies at appropriate milestones against timeline
Requirements:
- BS or BA in business or a scientific discipline
- Proficient in Microsoft Office and Microsoft Project
- 2+ years work experience
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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Quality Assurance, Senior Facility Auditor
The Senior Facility Auditor will perform a wide variety of activities pertaining to ensuring compliance with applicable regulatory requirements by conducting both internal facility and vendor audits, and data and documentation reviews and analysis. The Senior Facility Auditor will lead and manage auditing activities and implement auditing systems to ensure compliance with GLP requirements.
Responsibilities:
- Assure GLP compliance of internal facilities and external contractors
- Influence and collaborate with employees, senior management, and clients, and assume a leadership role to drive change initiatives. May provide primary representation for QA in internal working groups. Acts as external representative for SNBL USA during conduct of vendor audits.
- Develop, lead, and manage an effective CRO/Vendor QA program. Create short and long term audit plans for a variety of preclinical research vendors utilized at SNBL USA. Conduct/manage external vendor audits. Analyze and trend vendor/CRO risks and issues in order to provide appropriate process improvements in the area of oversight and vendor compliance. Build and foster QA relationships with SNBL USA's preclinical research vendors.
- Plan and conduct/manage audits of internal systems, departments, and processes on a recurring basis including audits of equipment and facility records and qualifications, documentation supporting study activities and other facility data to assure compliance with appropriate regulations
- Identify compliance gaps in departmental processes and systems; provide risk-based compliance opinions and guidance. Regularly apply best practices and GLP principles to issues.
- Provide direct internal support for regulatory agency and client inspections and participate in preparation/review of inspection responses
- Analyze and trend internal/external audit results in order to correlate and promote appropriate internal process improvements and corrective actions.
- Maintain computerized files to support audit activities
- Recognize and support opportunities for functional area improvement. Act as a mentor and professional resource for junior level employees.
Requirements:
- Bachelor's degree (BS) required
- Seven years related experience in the pharmaceutical industry in GLP preclinical research or GLP Quality Assurance
- Experience and knowledge of computer systems validation, management of electronic data, and equipment qualification practices is highly desirable
- Experience with direct data auditing, especially within a GLP environment required
- Direct experience in vendor management and conducting and/or responding to vendor audits required
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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Quality Assurance Validation Auditor
The Validation Auditor will perform audits of qualification and validation processes to assure compliance with regulations. The QA Validation Auditor will schedule, coordinate and perform annual facility audits to ensure departmental compliance with the regulations and may audit study data, reports and supporting documentation for internal accuracy, consistency, and conformance with regulations as needed.
Responsibilities:
- Perform audits of equipment qualification and computerized systems validation projects for accuracy, consistency and conformance with 21 CFR Part 58 and 21 CFR Part 11 and company Standard Operating Procedure requirements (SOPs)
- Perform periodic audits of ongoing software program use, maintenance and change management to ensure continued conformance with 21 CFR Part 58 and 21 CFR Part 11 and company SOP requirements
- Participate in Computerized System Vendor/Supplier audits to help determine the suitability of the vendor's quality management system, system development practices, system testing/ release/maintenance practices, system/data security practices, data management practices, and overall customer support
- Perform facility audits to ensure departmental compliance with the regulations
- Prepare, issue and track reports of observations noted during audits and inspections
- Apply expertise to help solve compliance issues and meet company objectives by using root cause analysis techniques
Requirements:
- Bachelor's degree (BS), specializing in computer science or equivalent combination of education and experience
- One to two- years of computerized system validation-related experience within an FDA- regulated environment with 2-4 years of GLP QA experience
- Experience and knowledge of computer systems validation and management of electronic data
- Experience with direct data auditing, especially within a GLP environment required
- Mechanical and scientific analysis skills; ability to solve practical problems and deal with a variety of concrete variables
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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Research Associate - Test Article
The primary responsibilities of the Research Associate - Test Article include: performing basic test and control article formulation, dose preparation and dispensing; receiving test and control article materials; maintaining chain of custody documentation associated with test and control materials, including inventory control.
Responsibilities:
- Prepare, sample and dispense dosing for non-GLP studies (primarily), however, as the team members gains experience in the position, may support GLP studies
- Maintain material inventory
- Reconcile materials as needed
- Document accurately, with limited errors
- Demonstrate increasing proficiency in understanding Xybion daily schedules for completing daily dose worksheets
- May be assigned as a Formulation Lead for non-GLP studies, including Day 1 preparation activities
Requirements:
- BA or BS in a scientific discipline
- 0-1 years in a regulated environment, equivalent combination of education and work experience may substitute for education requirement
- Ability to read and interpret documents such as study schedules, SOPs, etc.
- Ability to operate laboratory equipment
- Flexibility to work with a diverse group of people in a fast-paced environment
- Ability to work cross functionally on process improvements
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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Senior Accountant
The Senior Accountant will join the Business Services/Accounting team to provide technical support and management of the Finance Department. This position will report directly to the Finance Director and have the responsibility for applying accounting principles and procedures to analyze financial information, prepare accurate and timely financial reports and statements and ensure appropriate accounting control procedures.
Responsibilities:
- Compile and analyze financial information to prepare financial statements including monthly and annual account
- Ensure financial records are maintained in compliance with GAAP
- Ensure accurate and timely monthly, quarterly and year end close
- Resolve accounting discrepancies
- Manage and support on-going budget forecast activities
- Develop and maintain financial databases
- Ensure accurate and appropriate recording and analysis of revenues and expenses
- Analyze and advise on business operations including revenue and expenditure trends, financial commitments and future revenues
- Record/track revenue and supplies on hand
- Prepare financial management reports
- Facilitate financial audit preparation/coordinate the audit process
Requirements:
- BS/BA degree specializing in Accounting
- 8+ years related accounting experience in a mid-sized corporate accounting department and/or training; or equivalent combination of education and experience required
- 5+ years experience in the management of financial systems and budgets, financial reporting, financial data analysis, auditing and taxation
- Knowledge of: GAAP, auditing practices and principles, applicable laws, codes and regulations
- Great Plains experience
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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Senior Human Resources Manager
We are currently seeking a Senior Human Resources Manger to develop, operate and coordinate the Human Resources (HR) function of our organization. Reporting to the CFO, the candidate will formulate and recommend HR policies and objectives for the Company. The candidate selected will have exceptional leadership skills and be able to demonstrate successful representation of HR in communications with others.
Responsibilities:
- Oversee all HR functions to ensure that human resources supports corporate goals and objectives
- Develop and implement strategic HR policies and guidelines in accordance with corporate philosophy and strategy
- Advise the leadership team on HR-related issues including staffing and recruiting needs to effectively utilize the existing workforce
- Ensure compliance with legal requirements and government reporting regulations affecting HR functions and ensure policies, procedures & reporting are in compliance
- Develop performance review strategies for all levels of employees
- Oversee and negotiate contracts with benefit providers for medical, dental, vision, pharmaceutical, short/long term disability, life insurance, EAP and retirement programs
- Develop and manage capital resources & operational planning process in partnership with the leadership group
Requirements:
- BA/BS degree, specializing in Human Resources or related field; MBA and PHR/SPHR preferred
- 5+ years managing the overall function of the human resources department and assisting senior management with planning and compliance
- Advanced knowledge of Microsoft Office suite of programs: Word, Outlook, PowerPoint, and Excel
- Excellent communication skills, the ability to effectively and professionally represent SNBL USA in all internal and external communications
- Provide leadership, work collaboratively on teams and consult effectively and independently with all levels of the company
- Meet deadlines as assigned, handle multiple priorities and complex tasks on a routine basis and track and help drive completion of key deliverables
- Experience with bioscience, multinational and/or highly regulated companies preferred
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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Systems Analyst Associate- Information Systems
The Systems Analyst Associate will perform functions to support SNBL USA applications including reporting services.
Responsibilities:
- Manage the Financial Systems, Human Resources Systems, Animal Tracking System (ARTS), Project /Program Management System (P2M) and other applications
- Work with users and system owners to capture query requirements, design and implement business reports and data management interfaces
- Interview end users and potential system owners to understand their needs and assist in selection of suitable software and data management solutions
- Coordinate systems issues with the helpdesk and 3rd party software providers and resolve them in a timely fashion
- Perform tasks related to administration of systems including monitoring jobs and installing software upgrades
- Develop and manage business specifications, technical specifications, training and other project documentation
- Design, develop, install, test and maintain data interfaces and reports to Oracle, MS SQL, Access and other types of data repositories
Requirements:
- BS/BA degree specializing in computer science, computer engineering or related field is desirable or 2 years of experience in similar position
- 3+ years of experience in supporting applications and reports
- Experience developing, programs, under Microsoft ASP.Net and C# environments
- Additional skills required include, but are not limited to: configuring, installing and supporting Windows OS and productivity applications; diagnosing, tracking and solving software problems
For consideration send cover letter, resume and salary requirements to: hr@snblusa.com.
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SNBL USA, Ltd. is an Equal Opportunity and Drug Free Employer
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