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  • Saint Charles, MO
  • Eurofins

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Scientist II: Method Development & Validation

Eurofins • Saint Charles, MO

Posted 1 month ago

Job Snapshot

Biotechnology, Pharmaceutical

Job Description

Eurofins Bioanalytical Services is a powerhouse large molecule biotherapeutic-focused, bioanalytical contract research organization that, since its formation in 2003, has actively supported the evolving needs of companies that develop biotherapeutics.

Eurofins Bioanalytical Services is searching for a Scientist II: Method Development & Validation in St. Charles, MO.

Scientist II: Method Development & Validation responsibilities include, but are not limited to, the following :

• Works effectively as a member of a team, under minimum direction, to achieve client and business deadlines

• Understands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and attends annual GLP training

• Responsible for the development, validation and transfer of immunoassays and bioanalytical methods with limited direct supervision (RIA, EIA, Flow Cytometry, Cell-Based Assays)

• Provides contracted method development and validation services consistently with delivery on time and high quality. Serves as project leader with ownership of all aspects of client projects

• Characterizes antibodies and performs reagent qualification

• Conducts evaluation of manufactured products and develops fit-for-purpose assays

• May serve as a Principal Investigator for projects as assigned

• Communicates project updates to internal and external clients with limited supervision

• Provides technical documentation in the form of validation plans, reports, deviation reports, test methods and tables with limited supervision

• Reviews validation data, validation plans and reports and provides technical leadership and constructive feedback to team members

• Provides leadership in process improvement projects in support of continued unit development.

• Provides technical leadership, mentoring and training to junior staff

• Provides troubleshooting, root cause analysis and assistance with method design

• Complies with internal and customer SOP's as required in training program; maintains an up to date training file

• Applies use of IT systems (ERP, LIMS, etc.) as required

• Contributes to tactical and strategic marketing practices and portfolio expansion for site services

• With minimum guidance, designs, plans and performs/manages routine and non-routine projects

• Applies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position

• Owns the accountability and responsibility for delivering to client needs and timelines

• Provides cross-functional support to other departments as required

• Adjusts work hours as needed to meet client deadlines

• Adheres to site environmental health and safety (EHS) requirements

• Demonstrates and promotes the company vision

• Regular attendance and punctuality

• Performs other duties as assigned

The ideal candidate would possess :

• Experience with operational process improvement programs

• Experience with direct client contact in industry

• Ability to read, write and interpret documents such as standard operating procedures and technical reports

• Ability to perform statistical analysis and data interpretation

• Ability to solve practical problems and troubleshoot assays

• Ability to multitask with good time management

• Organizational skills to manage multiple priorities

• Computer proficiency in MS Word, Excel and instrumentation software

• Proven ability to effectively communicate orally and in writing to coworkers, supervisors, and clients

• Proven ability to compile data and create data reports

• Have a positive attitude and genuine interest in the drug discovery and developmental process and impact to patient health

• Ability to work in a laboratory setting, meeting the physical requirements of laboratory experiments

• Excellent communication (oral and written) and attention to detail

• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Basic Minimum Qualifications :

• B.A. or B.S. with 7 years relevant experience

• M.A. with 5 year relevant experience

• Ph.D. with 3 year relevant experience

• Or equivalent combination of education and experience

• Previous Pharma and /or CRO, Clinical Laboratory experience required

• Experience in method development and validation

• Experience in designing and performing immunoassays

• Authorization to work in the United States indefinitely without restriction or sponsorship

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with additional hours as needed. Candidates currently living within a commutable distance of St. Charles, Missouri are encouraged to apply.

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

To learn more about Eurofins, please explore our website .

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Job ID: 13204
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