Research Scientist – Large Molecule Full-time NEW

Research Scientist

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This is a fully onsite role based at our GMP Laboratory in Greenfield, IN. We welcome applicants from all locations within the U.S.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

As a Research Scientist, you will conduct and provide technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR perform troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. You will design and execute method development/validation and/or extractable/leachable studies independently and interpret and review analytical data for self and others OR design and execute multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), methods and procedures. You will routinely act as the technical project leader for multiple projects, provide updates, review and evaluate data, write reports and protocols.

What You'll Do:

• Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in mass spectrometry or other related areas such as structural elucidation or extractable leachable testing in a variety of formulations and/or delivery systems. Designs and executes experiments independently for self and others.
• Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
• Leads analytical (procedural and instrumental) troubleshooting sessions.
• Assists business development group in technical sales and marketing, and presents posters at technical conferences.
• Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Education and Experience Requirements:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

Intermediate knowledge of general chemistry and separation science

Demonstrated knowledge of multiple applicable techniques such as: HPLC, ELISA, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC

Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance

Full knowledge of technical operating systems

Ability to independently optimize analytical methods

Ability to independently perform root cause analysis for method investigations

Proven technical writing skills

Proven problem solving and troubleshooting abilities

Effective written and oral communication skills as well as presentation skills

Time management and project management skills

Ability to mentor others on technical operating systems

Ability to independently review and understand project proposals/plans

Ability to work in a collaborative work environment with a team

Working Conditions and Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthroughs.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.