Research Scientist (HPLC, GMP)

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

As a Research Scientist, you will support the biopharmaceutical lab by conducting and managing method development and validation projects, troubleshoot instruments and methods, design and execute studies, and interpret analytical data. You will manage multiple projects, perform routine maintenance on instruments, and write reports and protocols. You will oversee multiple projects, perform routine instrument maintenance, and write reports and protocols. Additionally, you will provide clients with recommendations on technical and regulatory requirements, resolve technical issues, and allocate resources to meet deadlines.

Key responsibilities:

• Independently performs analytical method development, optimization, validation, and other specialty technologies studies.
• Perform method transfers for pharmaceutical and biopharmaceutical compounds.
• Designs and execute 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).
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Keys to Success

• 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 and Abilities:

• Demonstrated experience with HPLC and oligonucleotide method development/validation strongly preferred
• Previous experience in GMP environment preferred
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA mentorship
• 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

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Work 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.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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