Sr. Associate Scientist/Scientist - Downstream Process Development
About The Position
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The Sr. Associate Scientist/Scientist is responsible for downstream protein purification, process development, and protein characterization. The position will directly report to a Downstream lead and assist in downstream process development and tech transfer to a GMP manufacturing facility. In this role, the individual will assist and operate both routine and advanced analytical instruments as well as protein purification systems.
Requirements
- PhD or MS in Protein Science, Chemical Engineering, Biochemistry or a related field 1+ years (PhD); 5+ years (MS); 7+ years (BS) of relevant pharmaceutical or biotech experience
- Demonstrate a good understanding of protein chromatography and filtration methods and protein analysis techniques.
- Ability to discuss experimental design and fully execute experiments independently from purification setup to analytical evaluation.
- Must-have experience with: ÄKTA Protein Purification Systems and Unicorn software SEC-HPLC/UPLC
- Hands-on experience in: Purification Process Development 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
Responsibilities
- Support drug candidate optimization, selection, validation, and stability study throughout pre-clinical and clinical downstream purification development for antibody/protein.
- Support and closely work with research, cell-line development, upstream, analytical and formulation groups.
- 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 runs for pre-clinical studies.
- Perform HPLC/UPLC, CE, cIEF, octet and other biophysical techniques to support upstream, downstream, and formulation process development.
- Perform and report interim analysis of accumulated data to monitor the safety of the drug or procedure.
- Establish relevant process transfer documents and cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations including Standard Operating Procedures (SOP) draft and review. 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.
- Plan time to accommodate meetings and technical support with downstream and analytical team members in China-based R&D center.
- 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.
Benefits
- SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
