Research Scientist - Regulatory Submission / GMP

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.

• Support preparation of global regulatory submission sections, for late-stage and commercial programs as analytical method Subject Matter Expert (SME).
• Author and/or review technical documents such as method development report, method validation protocol and report, or method bridging.
• Assist with QMS activities (Change Control, Impact Assessment, Change Action Owner) related to method implementation & related activities.
• Perform data verification, trending and statistical analysis to support regulatory strategy and product characterization.
• Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and ongoing product lifecycle activities.

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ 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.

• Proficiency in analytical techniques, such as HPLC, CE, IEF, LC-MS, or impurity methods.
• Demonstrated experience in SOP and technical report writing, especially regulatory documents (e.g. BLA and RoW submission) is MUST HAVE .
• Experience in analytical development for biologics, particularly from late-stage development through commercialization.
• Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a plus.
• Familiarity with the GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP, applicable to analytical methods and commercial-stage CMC.
• Effective collaboration, communication, prioritization and multitasking skills.
• Familiarity with commercial program lifecycle, QMS systems, and regulatory submission expectations is preferred
• Proficiency in statistical analysis tools (e.g., JMP, GraphPad Prism) is desired.

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!