Lead Scientist I BioA (LCMS)

Labcorp•Indianapolis, IN

13h•Onsite

About The Position

In this role, you will lead and direct scientific work to support external methods and projects, serving as a Lead Scientist for non-regulated, GLP/GCP regulated studies while ensuring client programs meet Labcorp, client, and regulatory requirements in order to meet defined milestones along the drug development pathway.

Requirements

Bachelors (BA/BS) degree in a science or related field (i.e. chemistry, biology, molecular biology, immunology, biochemistry etc.)
5 years or more experience in advanced laboratory scientific methods or scientific investigation
Excellent communication and interpersonal skills are necessary as this is a VERY client-facing role
Proven ability to prioritize and manage time
Excellent attention to detail
Able to utilize word processing, databases, spreadsheet, and specialized software

Nice To Haves

Masters (MS) degree or PhD. in a science field (e.g. chemistry, biology, molecular biology, immunology, biochemistry etc.)
2 or more years of experience in a regulated laboratory setting
Experience and skill with Watson, eWorkbook, Nautilus, SoftMaxPro
Knowledge of regulatory agency scrutiny / guidelines

Responsibilities

Ability to lead and direct scientific work to support internal methods and projects, of moderate complexity.
Serves as an SD, RS, CS, LS or PI for non-regulated, GLP regulated and GCP regulated studies as applicable
Ensures client programs meet Labcorp, client, and regulatory requirements.
Develops and reviews protocols and sample analysis plans.
Reviews data with the method development team to ensure methods are ready for validation.
Approves validation methods and reviews sample analysis methods.
Independently reviews and approves raw data.
Serves as a SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies as applicable.
Evaluates data and tables to ensure regulatory guidelines and expectations are met.
Reviews, edits and approves reports for scientific accuracy and completeness.
Provides technical support/technical input as needed.
May guide efforts to troubleshoot and solve assay problems.
Recognizes the functions of different teams within Labcorp and seeks guidance when appropriate.
Participates in scientific investigations.
Approves QA project specific inspections.
Approves data archival.
Serves as the scientific point of contact for the client.
Works with the client to determine project requirements.
Gives scientific directives to the study team.
Identifies scientific issues or scope changes within the study.
Communicates and monitors scientific expectations with scientific staff.
Proactively identifies ways to increase client satisfaction.
Promotes quality within the study team.
Provides a technical resource for less experienced team members.
Actively promotes collaboration within and across groups.
Provides appropriate coaching and recognition to team members.
Promotes a positive impression of Labcorp internally and within the industry.
Able to plan, prioritize, and manage workload for large and complex projects.
Demonstrated ability to manage high volume study work for key clients.
Takes accountability and demonstrates responsibility regarding scientific study conduct.
Good knowledge of client requirements.
Manages time effectively.
Performs other related duties as assigned.