Scientist, Method Development and Validation

Requisition Number: 1872

Position Title: Scientist, Method Development & Validation

External Description:

SUMMARY: A Scientist in Method Development and Validation is responsible for performing validation studies ranging from routine to complex using accurate and efficient analytical techniques. This individual will master relevant laboratory functions, works with great efficiency, and recommends and implements improvements.  With experience and demonstrated proficiency, they may be assigned method adaptation, transfer, or development projects in part or in full.

RESPONSIBILITIES:

Tasks may include but are not limited to: 

• Conduct method validations in accordance with applicable SOPs, GLPs, and protocols
• Review and approve data, recognize and report problems with accuracy and precision, and diagnose root causes
• Understand and apply GLP guidelines in relevant projects
• Document all procedural processes promptly and clearly
• Accurately prepare stocks, reagents, standards, and quality controls
• Perform relevant mathematical calculations
• Operate, maintain and calibrate instruments and equipment, as required
• Use scientific judgment regarding the quality and integrity of data and seek technical and management assistance when needed
• Follow Worldwide’s safety guidelines and perform tasks in a safe manner
• Perform complex chemical assays with consistent accuracy and precision
• Work independently, when required, to plan and conduct laboratory work
• Interface with clients when necessary
• Provide regular written and non-written communication of project status
• Evaluate the potential to automate assay procedures and implement automation whenever possible
• Adapt existing assays for new objectives
• Transfer and optimize client-owned assays
• Develop basic bioanalytical methods for client and Worldwide owned assays
• Train staff in the execution of established assays and technologies
• Review analytical test methods
• 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:

• Ability to read, execute, and understand complicated and detailed instruction and technical literature in order to plan, perform, and direct laboratory activities
• Familiarity with laboratory equipment associated with direct experience, experience after technical institute training, or a college degree in a related field
• Fundamental knowledge of industry regulations in bioanalytical method validation; FDA and EMA
• Ability to manage his/her time in order to meet task deadlines; effective time management
• Ability to work well with a variety of laboratory personnel
• Excellent communication skills, verbal and written
• Excellent attention to detail
• Basic computer knowledge
• Ability to work with constant interruptions
• Fundamental knowledge of separation science
• Fundamental knowledge of mass spectrometry
• Fundamental understanding of quantitative analysis and experience with its application to biological samples
• Familiarity with corporate policies, goals, and objectives
• Ability to understand graphs, tables, charts and perform relevant calculations
• Familiarity with various divisions of Worldwide

REQUIREMENTS:

• Bachelor’s degree, with a scientific focus, and five or more years of relevant work experience required

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IND-MS1

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Scientist, Method Development and Validation

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Austin, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.