Bio Analytical Scientist
Job Number: 23-03202
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Bio Analytical Scientist for our client in Seattle, WA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- An enthusiastic, self-driven Scientist to join its Residual, Ancillary Materials and Protein Characterization analytical development team.
- Lead development of analytical methods to characterize process-related impurities and assess impurity clearance in autologous and allogenic cell therapies.
- 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.
- Must have extensive hands-on experience in assay development and possess excellent communication skills in order 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.
- Should be passionate about developing Client medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.
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.
Required Qualifications:
- BS, MS or PhD in Molecular Biology, Analytical Biochemistry, Immunology, Microbiology, Cell Biology, or related field. PhD with 0-3 years, or MS with 3+ years, or BS with 7+ years of relevant industry experience.
- Knowledge or experience with vector and gene editing analytics (AAV, CRISPR, etc)
- 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).
- Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis/CE, etc.
- 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 Skills:
- Knowledge of immunology and T cell biology as applied to the cell therapy field
- 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
Pay Rate: $49.75/hr.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Chris Imbien
Chris.Imbien@eclaro.com
(843) 872-9257
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. •
Last updated on Nov 14, 2023