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Scientist - Process Development

Pharmaceutical Product Development (PPD)

Cambridge, Massachusetts, United States of America

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 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. 

To learn how Thermo Fisher's Clinical Research Group can advance your career, apply now!

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, scale-up experience, technology transfers and assay development preferred.

  • Similar experience in protein purification and chromatography experience will be considered.

  • Independent, detail-oriented, 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 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.

  • 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 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.

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.

Job posted: 2024-03-11

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