Research Scientist I / Research Scientist II Method Development - Bioanalytical Chemistry

Job Summary

We are seeking an experienced Research Scientist I and/or Research Scientist II for our Bioanalytical Chemistry team located in Ashland, OH.

Serve as a scientist in the conduct of assigned nonclinical or clinical LCMS/GCMS research studies of moderate to high complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects. Candidates with experience in large molecules and oligonucleotide analysis are highly encouraged to apply.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:  

• Research, design and execute LCMS/GCMS-based experiments for the characterization of biotherapeutics.

• Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.).

• Independently execute the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues.

• Independently develop and test quantitative/qualitative methods/procedures with increased complexity/scope in one operational area. 

• Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data.

• Develop and maintain 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. 

• Independently execute review and approval of data for final scientific/technical decisions.

• Responsible for reviewing the analytical procedures protocols independently. 

• Independently function as the scientific expert with internal and external stakeholders 

• Independently ensure scientific integrity of studies. 

• Provide support to staff members as required by operational areas, as needed. 

• Lead internal process improvements and training staff. 

• Attend scientific meetings, conferences, and training courses to enhance job and professional skills.

• Perform all other related duties as assigned.

The pay range for the RS1 position is 85-90K and the RS2 position is 100-115K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to: 

• Education and experience: Bachelor's degree (B.A./B.S.) in a related scientific discipline with 8 to 11 years of related lab experience, Master's degree (M.A./M.S.) with 5 to 7 years of relevant experience or Ph.D./D.V.M. with at least 3 years of related experience. PhD is strongly recommended.

• Certification/Licensure: None.

• Other:  Understanding of operating LCMS/GMS instruments and other typical small laboratory equipment, ability to manage multiple projects and prioritize work to meet deadlines, capable of data interpretation of biotherapeutics (metabolites, peptides and proteins, oligonucleotides) using analytical software (i.e. Analyst and Chromeleon), ability to learn Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.

PHYSICAL DEMANDS:

• Must be able to lift, move, manipulate and/or hold heavy objects up to and including 10 pounds; this includes work materials, equipment, and/or supplies.

• Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.

• Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.

• Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.

• Regularly operates a computer and other office productivity machinery, 

• Move about inside the work area to access file cabinets, office machinery, etc.

• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT:

• General office and lab working conditions, the noise level in the work environment is usually quiet.

• While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, and work with biohazards.

• The noise level in the work environment ranges from low to moderate depending upon the task being performed.