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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

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We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Bio Analytical Scientist

Job Description

  • Location: Seattle, Washington
  • Type: Contract
  • Job #79731

Our client, a leading pharmaceutical company, is hiring a Bio Analytical Scientist, on a contract basis.

Job ID #: 79731

Work Location:
Seattle, WA – on site

Summary:
Cell Therapy Product and Analytical Development (P&AD) is seeking an enthusiastic, self-driven Scientist to join its Residual, Ancillary Materials and Protein Characterization analytical development team. The Scientist will lead development of analytical methods to characterize process-related impurities and assess impurity clearance in autologous and allogenic cell therapies. The Scientist will be responsible for developing impactful methods, including QC methods for lot release testing as well as characterization methods that support process development and comparability assessments. These methods will be used to further our understanding of cell therapies, and support development of manufacturing processes, and/or QC release of the drug product. The successful candidate must have extensive hands-on experience in assay development and possess excellent communication skills to work on projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. Additionally, the Scientist will interface with external vendors (e.g., CMOs) for the successful management of any transferred analytical methods. The Scientist should be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.

Knowledge/Skills:

  • Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis/CE, etc.
  • experience working with Waters UPLC system and Empower software
  • Methods: SEC-U/HPLC, SEC-MALS, IEX, RP-LC, Affinity, CE: PA800 (SCIEX) CE-SDS, CZE, cIEF
  • Experience with proteins characterization preferred

Education/Experience:

  • BS, MS or PhD in Molecular Biology, Analytical Biochemistry, Immunology, Microbiology, Cell Biology, or related field. PhD with 1 year, or MS with 3 years, or BS with 7 years of relevant industry experience.
  • Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis/CE, etc.
  • Experience working with Waters UPLC system and Empower software
  • Methods: SEC-U/HPLC, SEC-MALS, IEX, RP-LC, Affinity, CE: PA800 (SCIEX) CE-SDS, CZE, cIEF
  • Experience with proteins characterization preferred
  • Strong problem-solving ability to troubleshoot complex technical and scientific problems.
  • Experience with writing technical and regulatory documents for interdepartmental use and external vendors (e.g., CMOs).
  • Strong attention to detail.
  • Outstanding written and oral communication skills.
  • Work effectively in a collaborative team setting.
  • Ability to work in a rapidly changing environment with frequent changes in priorities.

Preferred Qualifications:

  • Knowledge of immunology and T cell biology as applied to the cell therapy field
  • Knowledge or experience with vector and gene editing analytics (AAV, CRISPR, etc)
  • Experience with molecular techniques (e.g., qPCR, RT-qPCR, and/or ddPCR).
  • Experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, Excel, Prism Graphpad).
  • Familiarity with statistical analysis and design on experiments (DoE) using JMP software.
  • Track record of successful transfer and management of analytical methods has context menu

Responsibilities:

  • Serve as a subject matter expert responsible for developing robust analytical methods and expanding product and process understanding.
  • Independently develop and execute bioanalytical or molecular assays (e.g. chromatography, electrophoresis/CE assays)
  • Identify issues, lead troubleshooting experiments, and determine solutions with minimal to no guidance
  • Train users on method execution, data analyses, and proper use of instrumentation
  • Lead qualification and transfer of analytical methods to external stakeholders
  • Routinely present work at team, technical team, and department meetings
  • Maintain meticulous laboratory notebooks
  • Analyzing, interpreting, and presenting data to internal and external stakeholders (Power Point Presentations)
  • Author, review and approve technical documents, including methods, protocols, reports, and SOPs
  • Deliver lifecycle-managed analytical methods for multiple programs with an understanding of ICH/FDA/EMEA best practices and current thinking.
  • Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.

Pay Range: $54-$56/hr

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