Aptevo Therapeutics

Scientist/Sr. Scientist – Formulation & Analytical Development

Department: Development

Site(s): Seattle

Job Summary

We are seeking a candidate to support the formulation, analytical development and characterization of novel protein therapeutics in the Analytical Sciences group at Aptevo Therapeutics in Seattle.

• Designs and leads pre-formulation and formulation studies in accordance with ICH Stability guidelines to identify formulations appropriate for clinical trial and commercial use
• Acts as Aptevo lead representative for Drug Product (DP) contract manufacturing operations
• Develops, implements, and performs LC-MS and other types of analyses to support company product filings
• Interprets data and writes reports

Responsibilities

• Independently designs and performs all aspects of liquid formulation development including pH and excipient screenings; Develops novel formulation approaches for complex projects.
• Coordinates with members of purification process development and analytical development to conduct formulation experiments and analyze samples for purity and quality.
• Demonstrates knowledge of degradation pathways and independently designs off-platform formulation studies and assay development to address any degradation pathway or chemical modification.
• Leads person-in-plant activities and act as Aptevo representative at fill/finish contract organizations.
• Supports Quality Assurance with executed batch record review for all UF/DF, formulation, and fill/finish for clinical programs.
• Designs and conducts experiments to characterize protein structure and quality

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

• Ph.D. (Pharmaceutical Sciences, Analytical Chemistry, Biochemistry) with 0 – 2 years of experience or MS/BS (Pharmaceutical Sciences, Analytical Chemistry, Biochemistry) with at least 5 years of experience
• Experience developing liquid/frozen formulations for protein therapeutics, UF/DF operations, selection of appropriate vial and fill volume, etc.
• Prior experience working with external contract manufacturing organizations to fill/finish drug product for use in clinical trials
• In-depth knowledge of protein folding and mechanism leading to protein aggregation/ particle formation
• Familiar with use of “Design of Experiments” and associated software such as JMP to design formulation screening experiments
• Experience in biophysical instrumentation e.g. particle analysis, Differential Scanning Calorimeter, Circular Dichroism, Biacore, fluorescence assay etc is a plus
• Experience in analytical instrumentation e.g. HPLC, LC-MS is a plus
• Experience developing lyophilized drug product formulations is a plus.

Physical/Mental Requirements

Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 25 lbs, and pull 25 lbs. Use phone, fax, copier, and computer. Use hand tools and operate fork lift. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Drive automatic/standard vehicle. Work outdoors, around noise above conversation level, in hot/cold temperatures, in high humidity, where ventilation is needed, in multiple locations, with restricted access to laboratory, 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: 02/20/2021