Scientist - Process Development - Cambridge, United States - Thermo Fisher Scientific

Mark Lane

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Mark Lane

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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 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.


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 Thermo Fisher's Clinical Research Group team.


Responsibilities:


  • Complete the Design and execution of experiments to support process development of advance novel vaccine programs from preclinical through clinical stages under supervision, maintaining good scientific practice.
  • Complete process characterization studies per current program
  • Complete data analysis from process characterization / process development studies
  • Support the development of new processes or improve existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.
  • Complete Tech transfer of developed processes to support GMP manufacturing.
  • Complete archiving of raw and processed data as per policy
  • Operate and maintains designated lab equipment and train others as needed.
  • Complete additional duties and responsibilities as required.
  • Complete the documentation of experimental results as per GMP/GLP regulations.

Education and Experience:


  • Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering or equivalent and relevant formal academic / vocational qualification
  • AND 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job
  • 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._

Preferred Experience:


  • Experience in a GxP environment
  • Experience with Tangential Flow Filtration (TFF)
  • Experience in analytical testing and characterization techniques

Knowledge, Skills and Abilities:


  • Understanding of operations and GMP manufacturing
  • Industry experience with process characterization, process development, scaleup experience, technology transfers and assay development preferred.
  • Similar experience in protein purification and chromatography experience will be considered.
  • Independent, detailoriented, and organized with excellent oral and written communication skills.
  • Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.
  • Able to maintain written records in the form of laboratory notebooks / electronic lab notebooks (ELNs).
  • Ability to utilize Microsoft Excel and Word to perform tasks
  • Proven problem solving and troubleshooting abilities
  • Proven ability in 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 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 nontraditional 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.
  • As a condition of employment with PPD, in this role, you must have received your Covid19 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 complex 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.

Thermo

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