Scientist - Biologics R&D
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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 demonstrate 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.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the team.

A Day in the Life:

Biologics development GxP laboratory seeks a hard-working, results-focused Research & Development (R&D) scientist with experience in protein analysis to bring a world-class R&D Biologics portfolio to market. The position will be located in New Brunswick, NJ within the Biologics GxP - Compendial Testing Group.

• Independently perform biologics assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.
  
• Complete analytical testing of biologics including but not limited to compendial methods, wet chemistry techniques, Protein Concentration by UV/Vis spectroscopy (A280), Particulate Matter, and other relevant methods to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).
  
• Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate, robust and reproducible analytical methods for use in the GMP clinical laboratory.
  
• Independently complete analytical method qualification/validation (as applicable) and transfer to external QC laboratories. Carefully adhere to approved protocols, as applicable.
  
• Perform duties in full compliance of relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.
  
• Review technical documents, reports, and protocols to assure technical merit, accuracy and completeness.
  
• Proactively provide clear, timely communication of potential issues to management.
  

Education and Experience:

• Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent
  
• AND 2+ year of previous experience that provides the knowledge, skills, and abilities to perform the job
  
• Experience in a GMP lab environment
  
• Experience with analysis of proteins in Research & Development environment
  

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:

• Good written communication skills. Able to independently author and review analytical methods, qualification/validation protocols and technical reports.
  
• Understanding of cGMP/GLP and GDPs practices and EHS requirements is critical. Ability to align with all applicable SOPs, internal requirements and external regulations is a must.
  
• Experience using Electronic Laboratory Notebook (ELN), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems for routing protocols/reports for review and approval is a plus.
  
• Ability to work in a dynamic environment as a great teammate with a strong work ethic.
  

• Ability to use Microsoft Excel and Word to perform tasks
  
• Proven problem solving and troubleshooting abilities
  
• Technical writing skills
  

Working Environment:

Thermo Fisher Scientific Clinical Research Group values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideaswith diverse groups of peoplein a comprehensible and reasonable manner.
  
• Ableto work upright and stationary and/or standingfor 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 technologywith 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.
  
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
  

Our 4i Values:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need.

#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

This job has expired.