Scientist II

Scientist II
Hourly Rate: $46 - $50/hr with medical benefits available at a cost
Contract Length: 1 year initial contract with possibility of extension
Location: 100% Onsite in Irvine, CA
Work Schedule: Standard first shift lab hours, Monday – Friday.

Orion Project Services and a market-leading pharmaceutical company have teamed up on an exciting contract opportunity for a Scientist II in Irvine, California. In this fully onsite role, you’ll perform cGMP cell-based potency assays supporting biologics manufacturing, while contributing to cell culture and banking, data review, technical reports, and quality system documentation.

Candidates should have a relevant bachelor’s degree and at least five years of related industrial experience, or a relevant master’s degree and at least three years, along with experience in a GMP-regulated environment. Experience with bioassays, ELISA, PCR, automation, aseptic cell culture, or cell banking is a plus.

Major Responsibilities:

• Perform cGMP cell-based potency assays testing in support of the manufacture of biologics products.
• Responsible for the timely completion of assigned laboratory testing.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.
• Generate and update SOPs.
• Adhere to and supports all EHS standards, procedures and policies.

Regulated Responsibilities (including cGMP and EHS):

• We are a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
• Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications:

• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
• Proficiency in quality systems, Microsoft Project, and Excel.
• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.
• Experience with aseptic cell culture and cell banking preferred.

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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.