Senior Scientist - Late Stage Commercial

Thermo Fisher Scientific • Boston, MA

289d

About The Position

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.

Requirements

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• 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
• Excellent technical writing skills are essential
• Hands-on experience and In-depth knowledge of biochemistry, cell biology or microbiology assays is required
• Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept
• Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
• Partners effectively with internal and external functions

Nice To Haves

• Experience in Gene and Cell therapy is desirable
• Experience of using JMP or similar statistical tools is a plus

Responsibilities

• Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
• Author and/or review technical documents, including method SOP, study protocol and technical report
• Be a Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
• Provide SME assessment for deviation, CAPA and change control
• Participate in internal and external meetings

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Outstanding career and development prospects
• Exciting company culture that stands for integrity, intensity, involvement, and innovation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree