Sr. Scientist - Principal Investigator
Sr. Scientist - Principal Investigator
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
At Thermo Fisher Scientific youll 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.
Location/Division Specific Information:
Department: Immunochemistry
Location: Richmond VA
Full time Benefits Annual Bonus 401k Matchand PTO
Summarized Purpose:
Performs sophisticated laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation calculates and analyzes data and records data in adherence with PPD SOPs and the industry. Routinely acts as the project leader on multiple projects interacts with clients reviews and evaluates data writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.
Key responsibilities:
Independently performs method validations method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal direction.
Prepares study protocols project status reports final study reports and other project-related technical documents.
Communicates data and technical issues to the client and responds to client needs and questions.
Mentors trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
Assists with quality systems and new equipment.
Assists in crafting method validation or method transfer protocols and establish project timelines.
Reviews interprets and analyzes data for technical quality and compliance to protocols methods SOPs client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
Keys to Success
Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification and previous experience that provides the knowledge skills and abilities to perform the job(comparable to 5 years)or equivalent combination of education training & experience.
OR Masters degree and previous experience that provides the knowledge skills and abilities to perform the job(comparable 3 years)
ORPhD
Knowledge Skills and Abilities:
Solid understanding and knowledge of general chemistry and separation science
Full understanding of laboratory requirements PPD & client SOPs ICH guidelines USP requirements and FDA mentorship
Ability to utilize Microsoft Excel and Word to perform tasks
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Effective oral and written communication skills
Proven track record in technical writing skills
Time management and project management skills
Ability to work in a collaborative work environment with a team
Proven problem solving and troubleshooting abilities
Ability to train junior staff
Demonstrated knowledge ELISA strongly preferred
Experience working with external clients/stakeholders strongly preferred
Experience with quality investigations and quality deviations strongly preferred
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!
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 100000 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!
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-*. 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
Required Experience:
Staff IC
Employment Type
Full-Time
