Associate Research Scientist

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• Environmental Conditions

Office

• Job Description

Associate Research Scientist

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. At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk; our award-winning 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 full-time 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 off-site 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 6-8 years of experience in a regulated laboratory or MS and 4-6 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, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!