Aptevo Therapeutics

Principal Scientist, Protein Sciences

Department: Research and Non-Clinical Development

Site(s): Seattle

Job Summary

This scientist-level position will be in the Pharmacology and Cell Sciences group. The qualified person will be responsible for development, qualification, and implementation of bioanalytical assays (PK, immunogenicity, and biomarker) to support pre-clinical, IND-enabling and clinical studies. This position will function as the bioanalytical laboratory lead for assigned projects and be responsible for data generation and interpretation while assuring compliance to internal best practices and regulatory guidance. Excellent communication and writing skills and an understanding of GLP guidelines are required.

Responsibilities

• Optimize and qualify bioanalytical assays with minimal guidance, including documentation and assembly of standard operating procedures and test methods, as defined by Good Clinical or Good Laboratory Practice guidelines (GCP and GLP)
• bioanalytical assay techniques and platforms such as ligand binding (ELISA, MSD, Luminex, etc.) and multiplexed biomarker analysis is required. Experience in statistical analysis is highly desired.
• Responsible for reagent and sample management and reporting of study data in a timely manner. Clinical assays must be run adhering to GLP/GCP guidelines following study protocols and test methods, with data being properly recorded.
• Independently execute, analyze, and interpret routine experiments and research technically relevant scientific literature to expand knowledge related to project specific work.
• With limited supervision, develop and run methods to determine concentrations of drug present in sera, as well as immunogenicity assays to look for development of anti-drug antibodies.
• Participate in report writing, business development and any form of public presentations, as required for projects, including contribution to regulatory documents as projects move into the IND enabling stage, and clinical documents for those in Clinical Development.
• Continue to develop new techniques and skill sets as needed for various projects and identify technical challenges and explore possible solutions with little guidance.
• Experience with flow cytometry methods and in vivo study planning and animal handling is a plus.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• Experience with ligand binding assays, multiplexed biomarker assays and platforms such as ELISA, MSD and Luminex.
• Knowledge of GLP and GCP guidelines for handling non-clinical and clinical samples, running clinical assays, recording clinical data and report writing.
• Proven ability to communicate experimental procedures and results through a variety of project and group team meetings and a willingness to work independently or collaboratively on multiple projects, keeping in mind company goals and timelines.
• Experience with flow cytometry methods is desired.
• In vivo handling skills, including SC, IV, ID, and IP injections, tumor implantation and measurement, blood sampling techniques, etc. is a plus.
• Excellent organization skills including accurate records and verbal presentation of work. Proficient use of MS/office, GraphPad Prism, SoftMax Pro, JMP and other computer programs useful in scientific experimentation and data analysis.
• Ability to multi-task across various programs and activities and troubleshoot efficiently with little guidance.
• BS degree and 8-10 years of related experience

Physical/Mental Requirements

Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 15 lbs. Use phone, fax, copier, and computer. Use hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, plan, communicate, prepare written communications. Work around noise above conversation level, where ventilation is needed, in multiple locations, with restricted access to laboratory, and in contact with Select Agents and with exposure to animals, animal areas, or equipment used in animal areas.

Apply here: https://aptevotherapeutics.com/careers/

Aptevo Therapeutics

Aptevo Therapeutics is an Equal Opportunity Employer

Submitted: 04/10/2021