Senior Scientist - Change Control Mgmnt

Work Schedule

Environmental Conditions

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.

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.

• Be the Analytical Development (AD) point of contact for change controls. Responsibilities include but not limited to: participate in change control review, evaluate potential impact to AD and collaborate with SMEs for joint assessment, initiate, track and close change control record
• Propose and implement ways to ensure and improve timely closure of change control, investigation, CAPA, ELN and completion of trainings
• Assist in the revision of governance SOPs for AD, including but not limited to Method Validation and Method Transfer, Establishing Specification
• Perform data verification to ensure accuracy and completeness of information presented in analytical documents and regulatory filings. Assist with comment resolution if needed
• Support internal audit programs to ensure compliance and pre-approval inspection readiness
• Support other analytical development activities as needed

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

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.

• Relevant Analytical Development, Quality Control or Quality Assurance experience is required
• Hands-on experience and In-depth knowledge of change control, deviations, CAPA and investigation
• In-depth knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept
• Attention to detail and follow up with collaborators to ensure timely completion of assignment
• Ability to communicate to a wide variety of audiences, exchanges complex and sensitive information and gain alignment around a proposed action
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
• Excellent technical writing skills are essential
• Experience in biologics, gene and cell therapy is desirable

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!