What are the responsibilities and job description for the Scientist II position at Mindlance?
Purpose:
The Bioanalytical group in the Department of Local Delivery and Translational Sciences is seeking a Scientist II to develop and optimize new ligand binding bioanalytical methods and perform sample analysis to generate reliable and reproducible pharmacokinetic (PK), biomarker and biodistribution data in a timely manner under the direction of a more senior scientific leader. The ideal candidate should have experience demonstrating an understanding of quantitative bioanalytical assays and related technologies. Furthermore, the ideal candidate should demonstrate the capability to read and adapt scientific literature to accomplish assignments and demonstrate broad and versatile PK and biomarker method development expertise or a closely related discipline.
Responsibilities:
• Independently develop and qualify PK and biomarker assays for various modalities in biological matrices, and document experimental procedures and results.
• Contribute to developing and qualifying analytical methods to characterize the biodistribution of Client gene therapy (GT) candidates using analytical methods such as tissue homogenization, digital PCR and ligand binding assays to measure levels of viral vector DNA, RNA and transgene product in biological samples.
• Perform non-GLP sample analysis for non-clinical toxicology and PK studies.
• Use statistical tools to analyze and interpret data to design follow-up experiments needed to complete assay development.
• Write and review assay development protocols, assay qualification reports, and bioanalytical reports as needed.
• Present results to management and at cross-functional meetings.
• Collaborate effectively within the group and with other departments to advance ***’s large molecule programs.
• The position requires working with select agents and/or in areas that require select agents and toxins access. Candidate should understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, drug product and select agent, GxP compliance.
• Maintain laboratory equipment and optimize laboratory operations for efficient use of time and laboratory supplies and reagents, when appropriate.
• Assume additional responsibilities to support safety and organization of the lab.
Qualifications:
• Bachelor’s Degree with 5 years’ experience or Master’s degree with 2 years’ experience in Biological Science, Biochemistry or similar field required.
• Prior experience in PK, biomarker analytical method development, molecular biology, AAV and CRISPR Gene Therapy is highly preferred.
• Candidate should be proactive, inquisitive and a self-starter who is eager to learn and thrive in fast paced environment.
• Hands-on laboratory experience in support of biologics drug development and within a matrixed team environment is preferred.
• Ability to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2).
• Compliance with ***’s internal and applicable regulatory requirements involving ethics, environmental health and safety, financial, human resources, and general business policies required.
Competencies:
• Excellent written and oral communication skills to effectively communicate complex research findings and recommendations.
• Ability for critical thinking and strong analytical skills to evaluate complex information for the identification of key scientific findings related to projects.
• Ability to prioritize and manage multiple projects and activities while meeting tight deadlines
• Maintains excellent working relationships with colleagues and collaborators.
• Independent, innovative, and creative thinker.
• Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
The Bioanalytical group in the Department of Local Delivery and Translational Sciences is seeking a Scientist II to develop and optimize new ligand binding bioanalytical methods and perform sample analysis to generate reliable and reproducible pharmacokinetic (PK), biomarker and biodistribution data in a timely manner under the direction of a more senior scientific leader. The ideal candidate should have experience demonstrating an understanding of quantitative bioanalytical assays and related technologies. Furthermore, the ideal candidate should demonstrate the capability to read and adapt scientific literature to accomplish assignments and demonstrate broad and versatile PK and biomarker method development expertise or a closely related discipline.
Responsibilities:
• Independently develop and qualify PK and biomarker assays for various modalities in biological matrices, and document experimental procedures and results.
• Contribute to developing and qualifying analytical methods to characterize the biodistribution of Client gene therapy (GT) candidates using analytical methods such as tissue homogenization, digital PCR and ligand binding assays to measure levels of viral vector DNA, RNA and transgene product in biological samples.
• Perform non-GLP sample analysis for non-clinical toxicology and PK studies.
• Use statistical tools to analyze and interpret data to design follow-up experiments needed to complete assay development.
• Write and review assay development protocols, assay qualification reports, and bioanalytical reports as needed.
• Present results to management and at cross-functional meetings.
• Collaborate effectively within the group and with other departments to advance ***’s large molecule programs.
• The position requires working with select agents and/or in areas that require select agents and toxins access. Candidate should understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, drug product and select agent, GxP compliance.
• Maintain laboratory equipment and optimize laboratory operations for efficient use of time and laboratory supplies and reagents, when appropriate.
• Assume additional responsibilities to support safety and organization of the lab.
Qualifications:
• Bachelor’s Degree with 5 years’ experience or Master’s degree with 2 years’ experience in Biological Science, Biochemistry or similar field required.
• Prior experience in PK, biomarker analytical method development, molecular biology, AAV and CRISPR Gene Therapy is highly preferred.
• Candidate should be proactive, inquisitive and a self-starter who is eager to learn and thrive in fast paced environment.
• Hands-on laboratory experience in support of biologics drug development and within a matrixed team environment is preferred.
• Ability to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2).
• Compliance with ***’s internal and applicable regulatory requirements involving ethics, environmental health and safety, financial, human resources, and general business policies required.
Competencies:
• Excellent written and oral communication skills to effectively communicate complex research findings and recommendations.
• Ability for critical thinking and strong analytical skills to evaluate complex information for the identification of key scientific findings related to projects.
• Ability to prioritize and manage multiple projects and activities while meeting tight deadlines
• Maintains excellent working relationships with colleagues and collaborators.
• Independent, innovative, and creative thinker.
• Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
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