The Offer
- Work in a company with a solid track record of performance
- Opportunity to make a positive impact
- Fantastic work culture
The Job
Responsibilities :
- Manage a portfolio of sample analysis projects, ensuring timelines are met with minimal oversight.
- Execute, review, and approve data for final scientific / technical decisions within a single operational area.
- Develop understanding of compliance expectations and respond to quality assurance audit observations with minimal oversight.
- Assist in laboratory investigations, assay troubleshooting, and quality observations with minimal oversight.
- Independently solve technical and regulatory issues.
- Review study plans, protocols, and amendments.
- Participate in Sponsor visits and tours with minimal oversight.
- Develop and validate quantitative / qualitative methods and procedures with limited complexity / scope in one operational area.
- Perform data analysis using appropriate software.
- Develop critical thinking, troubleshooting, and time management skills aligned with operational needs.
- Communicate effectively with peers, supervisors, and team through informal discussions.
- Act as a liaison, maintaining communication between the organization and Sponsor / Client / SD.
- Ensure scientific integrity of studies.
- Function as a Principal Investigator, Individual Scientist, and / or Study Director.
- Collaborate across operational areas to adhere to timelines and produce quality data.
- Document all procedures, materials, and results in compliance with regulatory standards.
- Write, review, and approve deviations with minimal oversight.
- Understand regulatory and GXP requirements, industry standards, and company SOPs within one operational area.
- Manage a small portfolio of research projects including method development and validation.
- Recognize and communicate method and / or data issues to management with minimal oversight.
- Support staff members as required by operational area.
- Participate in internal process improvements, presentations, and harmonization efforts.
- Perform other related duties as assigned.
The Profile
Requirements / Qualifications :
- Bachelor's degree (BA / BS) with 7-9 years of relevant experience, Master's degree (MS) with 3-4 years of relevant experience, or Doctorate degree (PhD) with 1-2 years of relevant experience.
- LC / MS / MS experience required.
- Equivalent combinations of education and experience may be accepted.
- Strong verbal and written communication skills at all organizational levels.
- Basic familiarity with Microsoft Office Suite.
- Computer skills, including the ability to learn a validated system.
- Ability to work extended hours, including evenings, weekends, and extra shifts, sometimes on short notice.
- Ability to work under specific time constraints.
Must-have qualifications
- Doctorate degree (PhD) with 1-2 years of relevant experience.
- LC / MS / MS experience required.
- Understand regulatory and GXP requirements, industry standards, and company SOPs within one operational area.
- Sample Extraction, Sample Analysis, CRO, GLP, Software Analysis used : Waters
The Employer
Our client is a team driven by passion, committed to revolutionizing the way you experience recruitment and HR.
7 days ago