Scientist II

Scientist II (Analytical)
$42 - $45/hr medical benefits available at a cost
6 month initial contract
Located onsite in Irvine, CA
Standard laboratory hours 8 am to 5 pm M-F

Orion Group and our largest US client have teamed up once again for an exciting contract position in Irvine, CA! Our client is seeking Scientists with an understanding of CMC development strategies for Biologic drugs, and expertise in analytical and separation techniques.

Don’t pass on this amazing opportunity to join a market leading pharmaceutical company!!!

Job Summary:

The Scientist is responsible for supporting the development, qualification, transfer, testing, and validation of analytical methods with experience required in the following: HPLC (RP, SEC), gel and capillary electrophoresis (CE, icIEF), as well as compendial techniques (UV, KF, pH), in a cGMP environment.

He/She collaborates with scientific staff to plan experimental work and executes testing and protocols in support of biologics process development, formulation development, and stability studies. He/She independently carries out multiple analytical methods to support biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with internal and applicable regulatory requirements. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Responsibilities:

• Strong understanding, knowledge and ability to adhere to and apply Good Manufacturing Practices (GMP), guidelines and regulations ensuring products are consistently analyzed according to quality standards required in a GMP environment. Able to review GMP documents for adherence to applicable regulations.
• Possess a strong understanding of compendial methodology (USP/EP/JP).
• Review methods, protocols and SOPs for adherence to GMP principals.
• Support the development, qualification, testing, transfer, and validation of analytical methods for the analysis and characterization of neurotoxin and biologic entities via various separation techniques (HPLC, CE) and compendial techniques (UV, KF, pH, Osmolality).
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner.

Qualifications:

• Bachelor’s Degree or equivalent education with typically 3-5 years of experience, or Master’s Degree or equivalent education with typically two years of experience.
• Understanding in CMC development strategy of biologics drugs.
• A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• Experience with separation techniques including HPLC (RP, SEC), and CE.

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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.