Scientist/Senior Scientist - Downstream PD

Company: SystImmune
Location: Redmond
Posted on: May 9, 2022

Job Description:

Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.

Summary: The Sr. Associate Scientist/Scientist/Senior Scientist is responsible for downstream protein purification and characterization. The position will be leading downstream process development and tech transfer to GMP manufacture facility.

Essential Duties and Responsibilities:
Lead pre-clinical and clinical downstream purification development and stability study for antibody/protein.
Design and develop scalable and robust purification processes via affinity chromatography, IEX, HIC and CHT, etc.
Design and develop scalable and robust viral inactivation, viral filtration and tangential flow filtration process.
Generate low endotoxin production run for pre-clinical studies.
Perform HPLC/UPLC, CE, octet and other biophysical techniques.
Support drug candidate optimization, selection, validation, and stability study
Write and review Standard Operating Procedures (SOP)
Establish relevant process transfer document and cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations.
Perform and report interim analysis of accumulated data to monitor for the safety of the drug or procedure.
Prepare reports and papers of completed projects for publication in technical journals, patents, presentation to regulatory agencies or at conferences, or use in further research activities.
Support and closely work with research, cell-line development, upstream, analytical and formulation groups.
Work with R&D center in China to expand analytical capabilities. Plan time to accommodate meetings and technical support with team members in China
Support scientific discussions, high-level strategic scientific advice, inputs, and expertise to management, the Board, advisory groups, and scientific committees.
Coordinate with the ethics committee, which safeguards the rights, safety, and wellbeing of all trial subjects, and organize ethics committee submissions with follow through to ensure successful outcome.
Participate in timeline planning and decision-making regarding research priorities of company or department and provide information on feasibility of prospective projects.
Other duties as assigned.

Qualifications:
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education & Experience
PhD; MS; BS in Protein Science, Biochemistry or a related field with 2+ years (PhD); 6+ years (MS); 8+ years (BS) of relevant academic and/or pharmaceutical or biotech experience
Demonstrated A good understanding of protein purification mechanism and protein analysis
Hands-on experience in:
Purification Process Development
--KTA Protein Purification Systems and Unicorn software
Crossflow and Tangential Flow Filtration techniques
Column packing / unpacking
Viral inactivation and viral filtration process development / Viral clearance study
Low endotoxin production run
Process scale-down/scale-up
Setup and run protein analytical experiments
Ability to design and execute experiments independently

Language Ability
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Strong interpersonal, communication and collaboration skills to connect with internal and external CROs.

Math Ability
Ability to calculate figures and amounts such as percentages, area, volume, loading capacity and process recovery. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong scientific, medical, and analytical abilities with innovative, solution-oriented style.

Computer Skills
Proficiency with Microsoft Word, Excel, and PowerPoint required. Proficiency with email required.

Certificates and Licenses
None required.

Supervisory Responsibilities
This job may have supervisory responsibilities.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

This individual will work in cell culture laboratory alongside other scientists and in a standard business office with desktop business equipment and a moderate noise level.

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.

While performing the duties of this job, the employee is regularly required to sit for long periods of time. This individual must be able to operate standard laboratory and business equipment.

Keywords: SystImmune, Redmond , Scientist/Senior Scientist - Downstream PD, Other , Redmond, Washington