Scientist I, Bioanalytics - La Jolla, United States - AnaptysBio Inc

Description

AnaptysBio Inc
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Description:

Position Summary

This position is responsible for the development of all large-molecule bioanalytical assays for both clinical and nonclinical studies.

Essential Functions

• Support all bioanalysis efforts for preclinical and clinical studies, including biological activity, pharmacokinetics, pharmacodynamics, and immunogenicity analysis of antibody drug molecules.
• Design and execute bioanalytical experiments in support of preclinical studies and clinical programs in a fast-paced, highly interactive environment.
• Prepare documents and protocols for method transfer of assays to GLP/GCP approved CROs.
• Support the development of assays to measure the in vitro and in vivo interaction of biopharmaceutical drugs with their cellular targets.
• Develop, qualify and transfer cell based neutralizing antibody assays and PD biomarker assays.
• Review, present and report results to internal/external teams and internally authored technical reports.
• Design, author and review method validation plans, method qualification and validation reports, sample analysis plans and bioanalytical study reports.
• Manages and maintains equipment, reagents and dedicated laboratory environment needed to carry out assignments.
• Follows internal SOPs and ensures CROs are following current regulatory guidance in the development, validation and execution of GLP bioanalytical assays.
• Oversee day-to-day operations of the Pharmacology and Toxicology Lab.
• Mentor junior and new laboratory personnel.
• Develop an expanding technical and theoretical knowledge base in Bioanalytical assays with a growing understanding of the scientific literature in relevant areas of research.
• Maintain a detailed and well-organized record of experiments in an electronic notebook.
• Maintain familiarity with literature to propose and implement improved procedures and protocols and to aid in problem solving.

Supervisory Responsibilities

• None

Requirements:

Education & Experience:

• BS degree with 12-15 years, MS degree with 8-12 years of pharmaceutical industry experience in supporting bioanalysis for non-clinical, clinical studies and to support regulatory submissions.
• Experience developing, implementing and troubleshooting ELISA and cell-based assays.

Knowledge and Competencies: Ability to communicate clearly, and to report and present experimental results and analysis to company colleagues.

• Effective interpersonal skills, including excellent written and oral communication skills.
• Ability to multi-task, organize multiple assignments, and work on several projects simultaneously while adhering to deadlines.
• Ability to work effectively as a team player in a complex, changing environment.
• Self-motivated, independent, and results oriented.
• Team player intensely committed to success in a highly dynamic environment.
• Ability to work independently while also willing to follow protocols.
• Strong analytical and organizational skills, with high attention to details.
• Creates networks with key decision makers to effect change within the organization.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office and laboratory environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The noise level in the work environment is usually moderate.
• This position requires working with biological and/or chemical hazards.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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