PD- Downstream Process:Senior Research Associate / Associate Scientist / Senior Associate Scientist
Job Title: Senior Research Associate / Associate Scientist / Senior Associate Scientist
Department: Downstream Process Development
Reports To: Scientist FLSA Status: Exempt
Assists with, develops, and executes purification and characterization experiments using antibodies and Antibody Drug Conjugates while following Standard Operation Procedures. Analyzes and interprets scientific data. Supports and closely works with research, cell-line development, upstream, analytical and formulation groups.
Essential Duties and Responsibilities:
• Participate in pre-clinical and clinical antibody and antibody drug conjugate protein purification and characterization process development;
• Contribute to design and develop scalable and robust purification processes via affinity chromatography, IEC, HIC and CHT, etc;
• Perform viral inactivation and viral filtration process development;
• Conduct filtration processing using Crossflow and Tangential Flow Filtration techniques;
• Responsible to generate low endotoxin production run for pre-clinical studies;
• Work with wide variety of analytical methods, including but not limited to SEC-UPLC, IEX-HPLC, CE-SDS, cIEF, DLS, MALS, HCP and endotoxin analysis;
• Effectively and closely coordinate with colleague and research teams; Support other groups in candidate optimization, selection, and validation;
• Keep detailed lab notes record and ensure lab notes are specific to allow the process to be replicated by using the same steps and achieving the same results;
• Establish relevant cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations;
• Assist with developing plans for projects or study guidelines for projects prepared by manager to outline Standard Operating Procedures (SOP) and tech transfer documents;
• Participate and presents in PD focused groups and acts as a resource for employees within the department. Responsible in coordinating, training, and re-training other members of the lab;
• This position requires lifting of up to 50 lbs occasionally;
• Presents results of work, interprets data, and draws conclusions regarding presented material and overview of work. Able to consolidate all orthogonal methods into a meaningful data package;
• Plan schedules and weekly to-do lists and ensure the workload is prioritized;
• Recommends alternatives, researches new methods and may proactively discuss potential solutions to challenged assignments;
• Able to think critically and creatively and comfortable to work independently, consider appropriate resources for challenges and have strong organizational and planning skills;
• Plan time to accommodate meetings and technical support with team members in China;
• Ensure lab duties are completed, reagent and other materials are prepared, consumable materials are stocked, and measuring equipment is cleaned and sanitized as per cleaning instruction;
• Other duties as assigned.
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
• MS; BS in Bio/Chemical Engineering, Protein Science or a related field with 2+ years (MS); 4+ years (BS) of relevant academic and/or pharmaceutical or biotech experience
• Strong fundamental knowledge and experience in protein purification and characterization, including hands-on experience of:
- Purification Process Development
- ÄKTA 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
• Extensive experience with common bio-analytical methods including UPLC, HPLC, mass spectrometry, capillary electrophoresis, MALS, DLS, etc.
• Setup and run analytical experiment
• Ability to design and execute experiments independently
Ability to read, analyze, and interpret common scientific and technical journals. 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. Ability to speak Mandarin is a plus.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and sampling theory. Ability to apply concepts of basic algebra and geometry.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions in written, oral, diagram, or schedule form.
Proficiency with Microsoft Word, Excel, and Access required. Proficiency with email required.
Certificates and Licenses
This job has no supervisory responsibilities
Travel may be required
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. Work hours will be flexible to ensure cell culture processes are properly monitored and maintained.
This individual must be able to handle standard laboratory and business equipment. Infrequent, moderate lifting of at least 50 pounds is required. Moderate standing and walking; frequent sitting; use of arms and hands to finger, handle, and feel; frequent use of hands for keyboarding; occasional stooping, kneeling, or crouching are required. Close, distant, and peripheral vision and depth perception are used frequently. Environment is similar to office environment with quiet to moderate noise levels. Individual will work with toxic chemicals such as Antibody Drug Conjugates (ADC).