Associate Research Scientist
Associate Research Scientist
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Job Description
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OfficeJob Description
Associate Research Scientist
Thermo Fishers 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. At PPD part of Thermo Fisher Scientific we hire the best develop ourselves and each other and recognize the power of being one team. Its not just talk; our awardwinning training programs speak for themselves.
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 fulltime benefits.
Our client is seeking a highly motivated Associate Research Scientist to provide analytical support for pharmaceutical products.
Key Responsibilities:
- Contribute to the successful and timely of GMP analytical deliverables.
- Develop analytical transfer qualification and/or validation protocols and reports;
- Author analytical transfer qualification and/or validation protocols and reports;
- Collaborate with client QC groups and serve as a liaison on technical issues.
- Train third party personnel (e.g. analysts located at offsite manufacturing facilities) on analytical methods as appropriate;
- Order receive and manage inventory including shipments when appropriate of analytical samples critical reagents analytical cell banks and reference standard to support the effective transfer of analytical methods to and from internal and external parties;
- Support deviations vendor complaints and temperature excursion investigations which occur during shipping events
- Collect supply and document all the documentation related to the importation of materials including but not limited to samples critical reagents analytical cell banks and common laboratory reagents.
- Own and manage method life cycles apply appropriate tools to assess assay capability
- change management program
- Author review regulatory data as appropriate;
- Contribute to product specification development
- Assume responsibility for writing and reviewing SOPs. Protocols and other laboratory documentation as necessary
- Work closely within and across interdepartmental matrix teams t
- Work with QA Document Control and validation groups to ensure quality standards are maintained and/or enhanced
- Analyse and develop work processes and new thinking for continuous improvement;
- Ensure the timeliness and accuracy of deliverables.
Education and Experience:
BA/BS in Chemistry Biochemistry Biology or Microbiology with a minimum of 68 years of experience in a regulated laboratory or MS and 46 years of experience in a QC analytical laboratory.
In some cases an equivalency consisting 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:
- The individual should have training in pharmaceutical analysis.
- Must have very strong experience with cGMPs.
- Individual should be able to understand complex laboratory activities.
- Individual should be capable of writing reports related to work completed in laboratory.
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
IC
Employment Type
Full-Time
