About the position
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.
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
- 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
- Setup and run protein analytical experiments
- Ability to design and execute experiments independently
- 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.
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
- Ability to apply concepts of basic algebra and geometry.
- 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.
Proficiency with Microsoft Word, Excel, and Access required. Proficiency with email required.
Certificates and Licenses
This job may have supervisory responsibilities.
- 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 and molecular biology laboratories alongside other scientists and in a standard business office with desktop business equipment and a moderate noise level.
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 handle, assemble and manipulate bioreactor components and operate standard laboratory and business equipment.
Are you interested in this position?