Scientist I/II, Characterization

Job description

Scientist I/II, Characterization - Contract - Gaithersburg, MD.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Scientist I/II, Characterization in Gaithersburg, MD.

Role Description

We are seeking experienced Analytical Scientist I and II to join our team Analytical Development Characterization Team. The qualified individual should have experience on sample testing and product characterization using electrophoretic technologies such as SDS-PAGE, Osmolality, pH, Appearance, total protein analysis including A280 and Western Blot. Experience or knowledge on other analytical technology such as cell-based assays is a plus. ]

The position is responsible for in-process sample testing of biological products to support process development, formulation and qualification/validation of in-process testing assays. The position requires initiation and involvement in the development and qualification/validation of assays, OOS investigations and troubleshooting, writing SOP, development report and qualification/validation report. The ideal candidate will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.

• Develop, troubleshoot and/or optimize SDS-PAGE and Western Blot methods to ensure proper determination of sample purity and identity.

• Responsible for leading experimental designs to characterize Drug Substance and Drug Product materials for various batches generated from NVAX and/or CMO sites.

• Follow SOP to test in-process samples using SDS-PAGE densitometry, Western Blot, Osmolality, pH, Appearance, and Total Protein via A280 to support process development and stability studies of nanoparticle vaccines.

• Analyze gel image data using Image Lab and document in-process testing data.

• Responsible for drafting qualification and/or validation protocols for test methods to evaluate in-process samples

• Present sample testing data at internal meetings.

• Apply scientific expertise to select appropriate assays for the characterization and quality control.

• Provide scientific guidance for data interpretation, analysis and suitability of test methods, keeps abreast of relevant technology development and assists with implementation of new technologies.

• Implement and maintain GMP compliant instruments and testing where required, keep up-to-date on relevant quality, regulatory, and GMP environments.

• Train departmental staff on assays.

• Clear and effective communication with stake holders within and across relevant departments and project teams.

Skills & Requirements

• BS or a MS with a degree in biology, chemistry, biochemistry or equivalent.

• 2+ years of related or Biopharma experience.

• Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.

• Support testing and analysis in the vaccine sciences department (run assays, perform testing and analysis, prepare samples, maintain, and review lab documentation).

• Training or experience with microbiological lab techniques a plus (such as sample analysis, mammalian cell culture, cell line maintenance, passaging of cells, molecular techniques or similar relative experience).

• Good written and oral communication skills.

• Time management and project management skills.

• Proven problem solving and troubleshooting abilities.

• Ability to cross-train on sample preparation techniques with another laboratory group.

• Ability to work in a collaborative work environment with a team.

• Ability to be flexible with a workload and work schedule.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical

• Dental

• Vision

• 401K

• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.