Manage clinical and pre-market regulatory affairs projects including, Pre-IDE submissions, protocol development, IDE submissions, clinical site selection and initiation, clinical study progress, data management, monitoring, report preparation, and 510(k) submission.

ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES
Responsibilities include, but are not limited to:
• Prepare clinical study protocols, reports and other study documentation; prepare Pre-IDE, IDE, and 510(k) submissions.
• Generate CRFs, Informed Consent documents, Instructions for Use, Operator’s Manuals, and site training materials development for pre- and post-market studies.
• Interact directly with clinical sites, including clinical investigators and other health care professionals involved in the clinical study, and maintain a positive rapport with each site.
• Attend procedures to support sites (e.g., provide guidance in case report form [CRF] completion) and obtain product development feedback.
• Assist with monitoring clinical study data at sites to ensure regulatory and protocol compliance as necessary.
• Conduct other site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits), as required.
• Generate clear and concise trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc) and, as required, clinical summaries.
• Manage product inventories for clinical studies.
• Maintain study documentation (e.g., correspondence, deviations, budget information).
• Assist with manuscript and abstract preparation for publications.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and IDE) associated with preclinical and clinical studies.
• Act as a liaison between Calypso Medical and clinical sites.
• Maintain project schedules to ensure project milestones are met.
• Ensure projects are conducted within budgets.
• Serve as a clinical resource to other departments at Calypso.
 
SECONDARY RESPONSIBILITIES
• Follows all company safety policies and procedures while ensuring quality work.
• Handle changing priorities and other duties as required.

SCOPE OF WORK  
• Responsible for ensuring regulatory compliance of clinical studies.
• Responsible for developing departmental procedures and policies.
• Responsible for project planning.
• Responsible for own work products.
• Errors that are not quickly detected and rectified could have a significantly adverse effect on the quality of the clinical study data.
• Receives general supervision.
• Travel 50% at times.
• Potential OUS travel.

MINIMUM QUALIFICATIONS
• Degree/certification in life sciences, health sciences or equivalent degree/experience (e.g., BS, RN, etc)
• Experience with significant-risk medical device clinical studies and data collection
• Demonstrated project management skills.
• Demonstrated writing skills for protocols, reports, and manuscripts.
• Ability to follow and implement policies and procedures required of this position
 
SKILLS, ABILITIES AND OTHER REQUIREMENTS
• 5+ years experience with significant-risk clinical studies involving complex medical devices.
• Proficient in FDA regulations for clinical studies and medical devices, including GCPs and IDE regulations.
• Working knowledge of medical terminology.
• Experience with medical instrumentation and documentation of patient information.
• Comfortable with technology and scientific/engineering principles.
• Excellent knowledge of MS Word and good knowledge of MS Excel.
• Strong project management, documentation, and organizational skills
• Must be detail and accuracy oriented.
• Must have high standards for quality of work.
• Strong verbal communication skills and effective writing skills.
• Successful history in a team-oriented environment yet able to work independently.
• Must have a sense of urgency about problem-solving and completing projects.
 
PREFERENCES
• Experience with radiation therapy and/or oncology.
• Experience with clinical studies involving permanent implants.

If interested, please apply at http://www.calypsomedical.com/job-listings
  Calypso Medical Technologies, Inc. is an Equal Opportunity Employer

An excellent opportunity exists at Amgen’s Burnaby, British Columbia site to provide informatics support to biotechnology research groups, as a Senior Associate Information Systems Analyst. The position will be physically based in British Columbia but responsible for working remotely with virtual teams based in the US and across the globe.
This position will pro actively support a variety of IT needs for our scientific staff in the laboratory environment.  The successful candidate will be able to translate lab-computing needs expressed by clients into sustainable, standardized solutions.

This position will be responsible for:

• Deploying laboratory systems and keeping them up-to-date by maintaining security patch levels, matching appropriate computing hardware to instrumentation requirements, and managing laboratory services such as automated data backup and electronic data collection
• Representing local researchers’ needs to the global Information Systems teams and working collaboratively to deliver appropriate solutions
• Ensure vendor and contractor partner staff deliver services such as deskside, audiovisual and printer support.

The successful candidate will be an independent self-starter with a passion for providing informatics support that enables small and large molecule drug discovery research, specifically to aid in the discovery and development of novel therapeutics. Activities will include but not be limited to:

• Provide support for laboratory information systems including business analysis, problem identification, test, production support, hardware maintenance, and systems retirement.
• Respond to scientists’ needs by providing in-house developed or third-party systems in support of research projects.
• Establish and Maintain positive business relationships with local research clients and Amgen’s global Information Systems and scientific community.
• Consistently demonstrate an understanding of the scientific domain, laboratory processes, and the research priorities.

Basic Qualifications:

• Bachelors degree in Computer Science; Biomedical, Computer, Electrical, or Software Engineering; Mathematics; Chemistry or Biology; Physics;
• 3+ years experience in Information Technology support

Preferred Qualifications

• Strong understanding of the research laboratory environment
• Demonstrated ability to troubleshoot/repair/replace software/hardware for research instruments
• Ability to effectively communicate, both verbally and through electronic media, especially with a remote/virtual team
• Demonstrated ability to provide business systems analysis deliverables such as requirements documentation
• Demonstrated capability to multi-task and stay focused on priorities in a fast paced environment to meet deadlines
• Proven ability to self-direct and properly document processes and procedures
• Strong team player who is able to collaborate with colleagues on complex tasks
• Prior work experience that demonstrates strong customer service skills, effective analytical thinking, and attention to detail
• Experience developing solutions using VB, VBA, MSAccess and similar technologies
• Certification or demonstrated experience in the following operating systems: MS Windows, Unix: Linux, Solaris, Apple OS X and experience with Microsoft technologies for corporate environments (Windows 2000/XP/Vista, Active Directory, Group Policies, SMS, WSUS, RIS)
• Ability to prioritize tasks based on enterprise impact, functionality for users, network security, and Amgen corporate goals is critical
• Internship or industry experience
• Knowledge of software architecture and experience developing solutions using VB, VBA, MSAccess, and similar technologies
• Experience within an FDA-regulated industry (pharmaceutical, food, cosmetics)
• Past experience in designing and developing an information system or algorithm that solves a challenging informatics problem
• Demonstrated ability to abstract and generalize on specific situations to reach a practical solution
• Experience working as a productive member of a team and on a time bound project
• Experience implementing corporate IT projects and initiatives
• Experience in the implementation of laboratory instrumentation and data acquisition/analysis systems 

Company: AVI BioPharma

Position:  Project Director, Clinical Development Project Management

Location:  Bothell, WA (greater Seattle area)

I.                    Position Description: This key clinical position reports to the Vice President of Project Management.  The incumbent is responsible for effective management (organization, planning, execution, control and evaluation) of all aspects of the worldwide development of assigned drug product candidates for a program or a series of programs (or other at manager’s discretion) in a team matrix environment.

II.                  Position Responsibilities: The person in this position is expected to perform the following duties which include but are not limited to the following.

III.                Essential Job Functions/Accountabilities

Team Matrix Management

·         Lead one or more existing Product Development Teams, taking clinical development candidate drugs through final stages (IND enabling) of preclinical development and into full scale clinical development

·         Form the Product Development Team upon proposal of lead candidates from Discovery Research to the PDC for additional exon targets; and chair these 2-3 teams

·         Articulate the vision and strategy for the project(s)

·         Develop and execute project plans (with resources) that align with corporate goals

·         Anticipate major project risks and initiate actions to mitigate

·         Represent project in corporate forums and externally as requested

·         Identify execution issues and partner with appropriate line functions to resolve

·         Develop and maintain study specific timelines communicate and integrate within project timelines

·         Communicate study progress, issues, etc to VP and CMO

·         Develop and monitor project budget, working with finance to create tracking and accrual reports

·         Build strong and effective team environment

·         Act as liaison with funding, license or alliance partners

Other Documents and Submissions

·         Contribute to writing and review of reports and submissions

·         Support regulatory planning discussions, submissions and meetings

·         Undertake team training as needed and individual coaching

IV.               Supervision: Manage and train personnel assigned to program in functional capacity and department line, such as Project Manager/coordinator

V.                 Qualifications:  This position requires the following set of skills, competencies and experience.

Requirements

·         A minimum of 8 years experience in life science project management, including demonstrated successful delivery of on-time project execution and completion

·         In-depth experience with design and execution of pharmaceutical product development plans within budget

·         Excellent oral and written communication skills

·         Proficiency in problem recognition and solutions through collaborative interactions with colleagues across multiple functions

·         Excellent organizational skills that allow for changing company priorities and simultaneous activities

·         Superior leadership, diplomatic and human interaction skills

Proven negotiation skills

VI.               Other Skills/Abilities

·         Computer proficiency skills in MS Office Suite and database management tools

·         Prior global human pharmaceutical experience

·         PhD in life science  (biological, chemical, statistical, pharmaceutical or medical science) or a PharmD or MSc plus 12 years experience

·         Prior line management experience desirable

·         Experience with biological, peptide or particularly oligonucleotide manufacture would be advantageous, as would therapeutic area experience in pediatrics, neurology, antivirals, and/or orphan drugs

·         Ability to travel (~ 15% of time)

To apply for this position and for more information about AVI BioPharma, please see our Web site at:  www.avibio.com

• Coordinate the biomarker selection process including the management of two data curators (literature mining, public database searches, etc.), developing the biomarker selection process, monitoring and writing progress reports.
• Manage external service providers including defining requirements, workplan development, and monitoring progress against milestones. Responsible for establishing quality control on results and building strong inter-company relationships. 
• Responsible for the coordination of scientific and business management. This includes the prioritization of resources and projects in alignment with company goals and priorities.
• Facilitate upward, downward and lateral communications within the organization.
• Ensure integration and communication between internal teams including the bioinformatics/IT team, regulatory team and business development team.
• Obtain resources required for successful completion of milestones such as research tools (e.g. database licenses), samples for validation studies, establishment and maintainence  of ties with clinical collaborators, developing or identifying appropropriate software (e.g. project management tools, pathway analysis tools, etc.) and identifying key project needs and providing solutions.

• Coordinate the biomarker selection process including the management of two data curators (literature mining, public database searches, etc.), developing the biomarker selection process, monitoring and writing progress reports.
• Manage external service providers including defining requirements, workplan development, and monitoring progress against milestones. Responsible for establishing quality control on results and building strong inter-company relationships. 
• Responsible for the coordination of scientific and business management. This includes the prioritization of resources and projects in alignment with company goals and priorities.
• Facilitate upward, downward and lateral communications within the organization.
• Ensure integration and communication between internal teams including the bioinformatics/IT team, regulatory team and business development team.
• Obtain resources required for successful completion of milestones such as research tools (e.g. database licenses), samples for validation studies, establishment and maintainence  of ties with clinical collaborators, developing or identifying appropropriate software (e.g. project management tools, pathway analysis tools, etc.) and identifying key project needs and providing solutions.

Job Title:  Quality Control Associate

Department:  Quality Control

Requisition #:  1066

Quality Control Associate

CMC ICOS Biologics is a contract development and manufacturing organization (CMO) and is the US division of CMC Biologics, a Danish CMO.  The company manufactures protein-based biological drug substance candidates for human clinical trials under contract for biotech and pharmaceutical companies and has plans to move into commercial manufacturing in the near future.  CMC ICOS Biologics was created upon the acquisition of the biologics division of the former ICOS Corp., and hence retains many of the experienced staff from the former organization.  We are currently seeking high-performance individuals to join this exciting new business.

Responsibilities

• Perform routine testing including in-process, release and stability testing. Primary analytical techniques for routine testing include gel assays, EIAs and cell-based assays.
• Write and revise test methods and standard operating procedures.
• Support method transfer and method qualification activities by writing protocols and/or reports, and participating in protocol execution.
• Communicate clearly, efficiently and accurately with internal groups and/or customer project teams.

Requirements

• BS in Chemistry, Biology or other relevant discipline.
• Minimum 2 years QC related experience.
• Experience with cell-based assays is highly desirable. Experience with analytical lab techniques including gels (SDS-PAGE, IEF, etc.) and EIAs, is preferred. Experience with Capillary Electrophoresis (CE) is a plus.
• Ability to understand and evaluate analytical/technical data. Ability to troubleshoot assays or procedures.
• Ability to consistently put GMP knowledge into practice and demonstrate a high level of compliance with company documentation practices.
• Experience with validation and qualification of analytical procedures is a plus.
• Ability to interact constructively with coworkers and clients
• Familiarity with Microsoft Excel and Word
• Good organizational skills and attention to detail, ability to multi-task.
• Demonstrated ability to take ownership of QC goals and projects 

CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.  EOE

For immediate consideration please email your CV to Jobs@cmcbio.com or apply directly at www.cmcbio.com/cmcicos  highlighting the position in the subject line.

Job Title:  Engineer
Department:  Engineering
Requisition #:  1064

CMC ICOS Biologics is a contract development and manufacturing organization (CMO) and is the US division of CMC Biologics, a Danish CMO.  The company manufactures protein-based biologics for human clinical trials under contract to small and large biopharmaceuticals companies and has plans to move into commercial manufacturing in the near future.  CMC ICOS Biologics was created upon the acquisition of the biologics division of the former ICOS Corp., and hence retains many of the experienced staff from the former organization.  We are currently seeking high-performing individuals to join this exciting new business. 

JOB TITLE:     Engineer

Summary: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in operations or project environments.  Manage and/or apply advanced engineering principles in the coordination of multiple and complex projects involving planning, design, reconfiguration, construction, maintenance, and alteration of systems, facilities, and processes.

Responsibilities:

• Maintenance, calibration and operation of process, facility and utility systems / equipment
• Project management for facility and process improvement projects
• Development and implementation of engineering standards and guidelines
• Development and implementation of equipment reliability improvement projects
• Lead Event & Process Analysis via Root Cause Analysis tools & techniques
• Execution of Reliability Centered Maintenance (RCM) within core processes
• Technical review and evaluation of complex engineering processes
• Coaching and mentoring engineering colleagues
• Technical document generation and revision in support of operations
  

Requirements:

• Bachelor’s degree in Engineering and/or equivalent experience 
• 4 years engineering experience in Maintenance, Design, Process Improvement, Root Cause Analysis (RCA)
• Knowledgeable in the following systems:  Instrument and Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM); Pharmaceutical Utilities
• Proven expertise in planning/organization/execution of maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams.
• Demonstrates a disciplined approach to making decisions that are based on data and facts and is consistent with Vision/Business Goals and Values
  

CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE

For immediate consideration please email your CV to Jobs@cmcbio.com or apply directly at www.cmcbio.com/cmcicos  highlighting the position in the subject line.

Director, Strategic Development

SonoSite is the world leader and specialist in hand-carried ultrasound.  The Director of Strategic Development position works with the executive management team to identify and close external growth initiatives for the company.  This includes strategic acquisitions, business partnerships and alternative distribution channels for core ultrasound products.  As a key member of the SonoSite Business Development team, you will set strategy, identify potential partners/acquisitions, interface with external parties, and manage due diligence process and valuation analysis.

Experience we are targeting includes:
• 5+ years industry experience with 2+ years experience in business development; medical industry strongly preferred.  MBA and medical marketing experience a plus.
• Experience in conducting and / or coordinating analysis and diligence activities, including market research, intellectual property, technology, and distribution capabilities.
• Experience in valuation analysis.
• Experience in negotiating definitive agreements, contracts.
• Polished verbal and written communication skills a must.
• Proven ability to communicate and build rapport with both internal and external partners.
• Strong project management skills necessary to coordinate acquisition and diligence projects from beginning to end.
• Ability to travel to support project activities.
• BA, BS degree, MBA preferred

Visit our careers page at www.SonoSite.com/careers to apply and learn more about our exciting technologies and how you can make a difference!

SonoSite, Inc. (www.sonosite.com) is the innovator and world leader in hand-carried ultrasound. Headquartered near Seattle, the company is represented by ten subsidiaries and a global distribution network in over 100 countries. SonoSite’s small, lightweight systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high performance ultrasound to the point of patient care. The company employs approximately 750 people worldwide. SonoSite is an equal opportunity employer and strongly supports diversity in the workplace.

University of Washington School of Medicine

Department ITHS

Req#58991

The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.

UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow's physicians, scientists and other health professionals.

The Institute of Translational Health Sciences (ITHS) has an outstanding opportunity for a Cell Therapeutics Senior Associate. The ITHS is a partnership among the University of Washington, Seattle Children’s Hospital, and the Fred Hutchinson Cancer Research Center. The Institute’s mission is to foster clinical and translational research by developing novel collaborations, providing scientific services, clinical research facilities and technology cores, and offering educational programs in clinical and translational research. The ITHS is sponsored by NIH under the Clinical and Translational Science Award program (CTSA). For more information on the ITHS visit:  www.ITHS.org

The cell therapeutics senior associate will be responsible for oversight, coordination, and supervision of personnel and manufacturing activities related to the preparation of modified cell products that are utilized in clinical research protocols. The incumbent will be responsible for all aspects of production. Duties may include, but are not limited to; processing human blood and tissue, establishing and maintaining cell cultures, cryopreservation, performing assays, compiling and analyzing data, preparing data summaries, charts and graphs, operating analytical instruments, and documentation of all procedures. The incumbent will review batch record data obtained for compliance to specifications, report abnormalities, and assist in investigation and quality improvements.

Responsibilities

The incumbent is responsible for the implementation of procedures to optimize manufacturing processes under cGMP regulations. Specialized knowledge and expertise are used in performing technical aspects of the job, exercising judgment within generally defined practices and policies in selecting and optimizing methods and techniques for obtaining solutions. The incumbent will report to the director of the ITHS Translational Technologies and Resources Core (TTRC), and will be responsible for oversight of daily operations of the facility and staff, scheduling of work, and interaction with investigators utilizing the facility. The incumbent will serve as liaison between vendors, contractors, suppliers, maintenance, and repair personnel.

Job Duties    

• Oversee daily manufacturing operations, coordinating lab activities, and monitoring workload
• Schedule, train, and supervise personnel, including cross training to provide backup capabilities
• Perform a variety of cutting edge biotechnological procedures involving gene and cell therapies; manipulate human cells with genes and/or their products. These duties include:
• Processing human blood and tissue
• Establishing and maintaining cell cultures
• Cryopreservation
• Performing assays
• Compiling and analyzing data
• Preparing data summaries
• Operating analytical instruments
• Maintain cGMP documentation/notebooks to be compliant with federal regulations and federal audits
• Develop documentation for resource operations, including batch records and standard operating procedures
• Participate in preparation and submissions of INDs, annual investigator FDA reports, and institutional reports and grants as requested
• Review applications for use of facility and facilitate scheduling for cell infusion products for cell products manufactured within the resource
• Assist affiliated investigators in developing novel and innovative biological processes for gene and cell therapy clinical trials compliant with cGMP
• Interface with quality control and quality assurance to comply with policies established by QA Director. Assist quality control in coordinating product testing and facility monitoring
• Oversee instruction and training of affiliated investigator’s technicians in cGMP requirements, SOP’s and facility. Oversee affiliate personnel working in the laboratory
• Monitor and maintain equipment and coordinate annual lab shut-down for calibration, repairs and maintenance
• Work with senior staff in determining long-term goals and laboratory needs and in setting operating policies for the resource
• Perform other responsibilities as needed 

• Working knowledge of cGMP and FDA guidelines is required.
• High level of comfort in dealing with specialized mechanical and electronic equipment.
• Ability to work both independently and as part of a team.
• Must demonstrate excellent communication, diplomatic, and  interpersonal skills.
• Previous supervisory experience is preferred.