Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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 use 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:
Versatile, biologics development GxP laboratory seeks a hard-working, results-focused Research & Development scientist with experience in protein analysis to bring an outstanding R&D Biologics portfolio to market.
Independently perform biologics separation assays on monoclonal antibodies, fusion proteins, ADCs and fixed drug ratio combination FDRC products to support development of therapies, particularly against immuno-oncology (IO) and oncology diseases.
Perform electrophoretic based and chromatography based testing of biologics, including but not limited to CE-SDS, icIEF, SE-HPLC, RP-HPLC, CEX, Glycan and peptide mapping analyses, when needed, to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).
Demonstrate knowledge of analytical techniques to contribute to the development of phase-appropriate, robust and reproducible analytical methods for use in the GMP laboratory.
Independently implement analytical method qualification/validation, transfer to external QC laboratories. Carefully adhere to approved protocols, as applicable.
Perform duties in full compliance of Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.
Author clear analytical methods and technical reports.
Review documents, reports and protocols to assure merit, accuracy and completeness.
Proactively provide clear, timely communication of issues to management.
Education and Experience:
Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')
OR Master's 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.
Knowledge, Skills and Abilities:
Experience with analysis of proteins in Research & Development environment is required.
The candidate must have good written communication skills and the ability to independently author and review analytical methods, qualification/validation protocols and reports.
Ability to identify, communicate and remediate technical issues pertaining to protein separation analytics is key. Skill in communicating/advancing critical issues to appropriate management is needed.
Understanding of cGMP/GLP and GDPs practices and EHS requirements is needed. Ability to follow all applicable SOPs, internal requirements and external regulations is a must. Preferred candidate will have at least 1 year of experience in GMP environment.
Expertise using Empower, Electronic Laboratory Notebook (e.g. Velquest, Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems (e.g. Syncade-DCA) for routing protocols/reports for review and approval 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!
