Senior Scientist, Laboratory Operations ( Large Molecules)

The Scientist performs and manages tasks that result in accurate and timely method development and validation of chemical and biological entities in biological matrices in a regulated environment utilizing various analytical technologies. The Scientist also manages Sponsor relationships for assigned studies, ensures that study procedures are conducted in alignment with Sponsor specifications and timelines, and ensures that workflow is conducted in a manner that supports internal best business practices.

RESPONSIBILITIES:

At Nexelis a Q² Solutions company (Indianapolis), a Scientist routinely and independently:

• Designs method development and validation experiments for execution.
• Acts as a single point of accountability for assigned studies, including acting as the principal investigator (PI) for regulated bioanalysis studies.
• Maintains productive, professional scientific relationships with clients, including effective communication of scientific progress, issues, and timelines.
• Interacts constructively with co-workers, able to provide clear instructions to direct in-lab scientific staff and to confirm instructions were followed as described.
• Generates, interprets, and draws clear conclusions from analytical data.
• Effectively communicates analytical data/conclusions to clients and laboratory management.
• Able to support business development and/or management by presenting technical and/or sales presentations to customers.
• Authors and adheres to established standard operating procedures consistent with industry and regulatory guidance.
• Maintains training records, including working knowledge of GLP and OECD regulations.
• Operates, calibrates, and troubleshoots laboratory equipment and analytical instruments.
• Follows established laboratory and biological/ chemical safety procedures and practices Universal Precautions.
• Maintains confidential information.
• May be asked to serve in a mentoring/ coaching/ supervisory role.
• May serve in role of responsibility and oversight, e.g. duties on Special Assignments List. These duties or tasks will be limited to the competency of the employee and scope of their training.
• Other duties and tasks as assigned by Management.

REQUIRED KNOWLEGE, SKILLS AND ABILITIES:

• Experience in the development and validation of bioanalytical methods utilizing various analytical technologies and/or assay formats, including a deep understanding of the underlying scientific principles along with ligand binding experience
• Detailed knowledge and understanding of current industry guidance's and whitepapers related to regulated bioanalysis.
• Practical understanding of GLP/OECD regulations and the ability to apply them daily.
• Ability to provide clear instructions to direct in-lab scientific staff and to confirm instructions were followed as described.
• Ability to clearly and concisely convey analytical results in written, oral, and electronic formats.
• Proven ability to manage and coordinate multiple complex projects simultaneously, with minimal supervision.
• Skills required to troubleshoot instrument (i.e., maintenance, calibration, tuning, etc.), method, and/or process related issues.
• Strong communication skills, both oral and written.

SUPERVISORY RESPONSIBILITES:

• This position may have supervisory responsibility for scientists/technicians conducting bioanalytical work in the laboratory to support projects and studies.

SKILL REQUIREMENTS:

• Technical Skills: Must possess comprehensive technical knowledge in all aspects of developing and validating methods in a regulated bioanalytical laboratory, including an in-depth knowledge of the underlying science.
• Quality: Demonstrates accuracy and thoroughness in daily tasks.
• Professionalism: Reacts well under pressure, treats Sponsors and coworkers with respect, communicates with tact, accepts responsibility for one's actions, follows through on commitments, asks for and offers help as needed, gives and welcomes constructive feedback to improve performance.
• Judgment: Displays ability to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions; includes appropriate people in decision-making process.
• Adaptability: Manages competing demands, changes approach or method to best fit the situation, able to deal with frequent change, delays, or unexpected events, identifies and implements process improvement initiatives.
• Teamwork: Balances team and individual responsibilities, exhibits objectivity and openness to others' views, helps to build a positive team spirit, puts success of team above own interests.
• Ethics: Works with integrity and upholds organizational goals and values.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status