Senior Scientist - GMP Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.

This position will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. They will provide expertise in analytical assay life cycle management including method validations and transfers, quality event investigations, regulatory filings, and other activities to support to the commercial manufacturing and critical component release for late stage and commercial programs in the Cell and Gene therapy (CGT) portfolio. This is an office based position.

Key responsibilities:

• 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
• Participate in internal and external meeting
  
  

Education and Experience:

• B.S or above in Biology, Biochemistry, Analytical Chemistry and related fields.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 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, Skills and Abilities:

• Must Have
• Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concepts
• Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
• Excellent technical writing skills
• In-depth knowledge of molecular and/or cell biology techniques
• Partners effectively with internal and external functions, include contract testing organizations
• It is desirable to have
• Experience in Gene and Cell therapy
• Experience with NGS technology
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
• Experience of using JMP or similar statistical tools is a plus
  
  

Working Environment:

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.

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!