Research Scientist - BioChem ICH Regulations

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, youll 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.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

• Work independently or in collaboration with internal and/or external partners in analytical lifecycle management activities including method validation and method transfer
• Author and/or review technical documents, including method SOP, study protocol, technical report, and other regulatory agency facing documents
• Be a key Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and/or quality event remediation during release and/or stability testing
• Provide SME assessment for deviation, CAPA and change control
• Perform data trending analysis
• Perform in-lab experiments as applicable

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• RS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ 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 of relevant ICH and regulatory guidelines and good understanding of GMP concepts
• Excellent technical writing skills
• In-depth knowledge of analytical chemistry/biochemistry/molecular biology techniques including HPLC, UPLC, and/or flow cytometry
• Partners effectively with internal and external functions, including contract testing organizations

• Experience in gene and/or cell therapy and/or CRISPR gene editing
• Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
• Experience with critical reagent management
• Experience of using JMP or similar statistical tools is a plus
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency

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.

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!