Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting, Office
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.
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.
Key responsibilities:
- Work in a GMP laboratory performing method validations and transfers.
- Assist in laboratory investigations at commercial sites; method troubleshooting.
- Lab notebook review and data review
- Initiate and lead analytical change controls
- Author commercial methods
- Draft testing standards
- Partner in administration and maintenance of group SharePoint site
- Support documentation change activities within Pharma Analytical Sciences group
- Data verification for regulatory filings and responses, and JOS
Education and Experience:
- 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 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, Skills and Abilities:
- Experience with GMP, method validation, method transfer, and method troubleshooting.
- Experience using QMS system such as Infinity to manage change controls
- Familiarity with pharmaceutical laboratory techniques such as HPLC, GC, Dissolution etc.
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!
