What are the responsibilities and job description for the Senior Scientist, Leader of Bioanalysis position at Worldwide Clinical Trials - USA?
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers, and doers, and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does.Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
SUMMARY: The Senior Scientist, Leader of Bioanalysis, manages a team of analysts responsible for extraction analysis. The individual ensures analysts are properly trained and qualified to perform bioanalysis in a regulated environment. Provides mentoring and career development as needed. The individual works closely with management, Functional Leads, and Bioanalytical Study Managers to ensure clarity, good communications, and clear expectations for sample analysis project deliverables are met.
RESPONSIBILITIES:
Tasks may include but are not limited to:
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
REQUIREMENTS:
We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers, and doers, and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does.Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
SUMMARY: The Senior Scientist, Leader of Bioanalysis, manages a team of analysts responsible for extraction analysis. The individual ensures analysts are properly trained and qualified to perform bioanalysis in a regulated environment. Provides mentoring and career development as needed. The individual works closely with management, Functional Leads, and Bioanalytical Study Managers to ensure clarity, good communications, and clear expectations for sample analysis project deliverables are met.
RESPONSIBILITIES:
Tasks may include but are not limited to:
- Assign projects for each employee and coordinate their schedules with other related personnel such as Study Managers.
- Train personnel in various extraction techniques utilized for sample analysis.
- Oversee workflow and determine appropriate use of resources to accomplish deadlines.
- Contact other departments to clarify priorities, as needed.
- Monitor the performance of the employees on an ongoing basis and make appropriate communications regarding performance to employees and management.
- Communicate to each employee the job responsibilities and expectations for his/her position.
- Enforce company policies regarding the use of paid and unpaid leave and implement these policies consistently with all individuals in his/her group.
- Develop a written plan with each employee in his/her group to set mutually agreed upon career goals.
- Conduct all performance reviews for employees in his/her group to set and progress toward mutually agreed upon career goals.
- Make recommendations for promotions and salary increases for employees in his/her group.
- Counsel employees that are not meeting the expectations of their position and provide them a performance improvement plan when necessary. Terminate employees when deemed necessary. Provide supporting documentation to Human Resources.
- Participate appropriately in the interview process.
- Participate in sponsor audits.
- Review and approve timesheets for employees in his/her group.
- Work closely with others to ensure that methods are effectively implemented in production sample analysis labs.
- Participate in investigations to determine assignable causes for method failures.
- Review data recognize and report inconsistencies.
- Review Analytical Test Methods.
- Promote good documentation practices.
- As needed, serve in unexpected event investigations and review/approve UEI reports.
- Actively develop staff through training, coaching, and mentoring in scientific, technical and regulatory areas.
- Ensure staff compliance with required training of departmental GLP, SOP, safety, and other guidelines.
- Develop and implement procedures to reduce contamination in sample analysis.
- Monitor and track sample analysis scientist errors in support of improvement opportunities.
- Work closely with Automation to ensure that staff properly perform assays using automation for sample preparations.
- Evaluate the potential to optimize work practices and, whenever possible, implement it.
- Ensure the Bioanalytical Study Manager(s) are kept aware of sample analysis scientist issues.
- Contribute to strategic decisions particularly relating to procedures, training, and instrumentation.
- Understand and apply regulatory guidelines when applicable.
- Document promptly and clearly procedural processes and equipment use.
- Interface with clients as applicable to explain the root cause of problems.
- Follow Worldwide’s safety guidelines and ensure that staff perform tasks in a safe manner.
- Accomplish all necessary and applicable Worldwide training, including Standard Operating Procedures, Employee Handbook, and Health and Safety Manual.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Strong scientific background.
- Experience with various extraction techniques.
- Effective time management and interpersonal skills.
- Strong organizational and problem-solving skills and ability to set priorities.
- Ability to read, execute, and understand complicated and detailed instruction and technical literature in order to plan, perform, and direct laboratory activities.
- Working knowledge of liquid chromatography-mass spectrometry/mass spectrometry.
- Theoretical knowledge of separation science and mass spectrometry.
- Knowledge of quantitative analysis and experience with its application to biological samples.
- Excellent attention to detail.
- Basic computer knowledge.
- Working knowledge of Watson laboratory information management system (LIMS).
- Works well with a variety of laboratory personnel.
- Able to work with constant interruptions.
- Mentors and develops others.
- Has excellent oral and written communication skills.
- Able to generate and test hypotheses, draw definitive conclusions in a timely manner and report findings.
REQUIREMENTS:
- Bachelor’s degree, with a scientific focus, and ~ 8 plus years of relevant work experience required, preferably in a Laboratory, or CRO, providing training or oversight of job-related responsibilities around sample analysis and review of supporting documentation. People skills associated with leading a team of scientists are desired. Understand policies and procedures associated with bioanalysis and good documentation procedures is an asset. Excellent time management and project management skills and the ability to communicate effectively are assets.
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