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Research Scientist - Bioanalytical LC-MS/MS (Ohio)
Full Time
Ashland, Ohio, United States (This job is on-site)
Job description
Scismic is supporting the growth of an early-stage contract research organization (CRO) that has been in the business for over 75 years with over 20,000 employees and 110 facilities in over 20 countries around the world.
The company is seeking a Research Scientist to join their Method Development Bioanalytical Team site located in Ashland, OH.
Job Summary
The company is seeking a Research Scientist to join their Method Development Bioanalytical Team site located in Ashland, OH.
Job Summary
This position supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation and reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques, rapid LC separations, and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxP’s and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.
The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
- Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
- Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
- Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues with minimal oversight
- Effectively develop and validate quantitative/qualitative methods/procedures with increased complexity/scope in one operational area with minimal oversight
- Independently perform data analysis in appropriate software for a majority of analytical platforms within an operational area
- Independently operate laboratory instruments including their respective software applications for 1- 2 analytical platforms within an operational platform
- Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas
- Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
- Able to recognize method and/or data issues and communicate them to management to minimize study impact independently
- Independently prepare summary of method development data
- Write both study and non-study deviations with minimal oversight
- Full understanding of regulatory and GXP requirements, industry standards and company SOPs within one operational area
- Independently lead the lab staff in the completion of method validation studies
- Provide support to staff members as required by operational area as needed
- Actively participate in internal process improvements, presentations and harmonization efforts
- Performs all other related duties as assigned
Job Qualifications
Knowledge, Experience, Skills and Abilities required to accomplish the essential functions include but are not limited to:
- Bachelor’s degree (BA/BS) with 7-9 years of relevant working experience. Master’s degree (MS) with 3-4 years of relevant working experience. Doctorate degree (PhD) with 1-2 years of relevant working experience.
- Experience with small molecule bioanalysis using LC-MS/MS a must
- Previous experience in biotech, pharma, or working for a CRO is preferred but not required
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Ability to communicate verbally and in writing at all levels inside and outside the organization
- Basic familiarity with Microsoft Office Suite
- Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
- Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
- Ability to work under specific time constraints
- Ability to lift up to 30 pounds without assistance.
- Work environmental factors included, but not limited to: everchanging temperatures, visibility to subject study animals, and standing for 8 + hours per day)
- 0% travel
- This is an onsite position (no remote options)
Vaccine Mandate
The company is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19. Their main priority is the wellbeing, health, and safety of our people. They require proof of vaccination from all employees.