Sr. Scientist, Biologics Purification
Performs a variety of laboratory procedures in downstream process development, including chromatography, filtration, homogenization, refold, and/or centrifugation experiments. May assist with technology transfer of processes to GLP and cGMP facilities, and occasionally provide person-in-plant (PIP) support for critical manufacturing operations. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selection methods, techniques and evaluation criteria for obtaining results.
- Purification process development and lab-scale production.
- Chromatography screening and optimization using AKTA systems.
- Primary recovery including Homogenization, centrifugation and/or filtration of cells, inclusion bodies, or precipitates in addition to depth filtration.
- Protein Refold processes. Tangential flow filtration. Analytical assessment of process purity and performance. Lab-scale purification runs to support analytical, research, and GLP needs.
- Scale-up, tech transfer, and CMO manufacturing support. Demonstrates purification design through consistency runs and robustness evaluation. Tech transfers purification processes to CROs and CMOs.
- When necessary, supports CRO/CMO manufacturing through process demonstration, person in plant (PIP) coverage, and troubleshoots manufacturing issues.
- General duties include writing reports and protocols; interfacing with various departments, customers and partners; working in a team environment; maintaining documentation of experiments and/or batch records according to good documentation practices; managing daily lab operations including stocking consumables, lab organization and cleanliness, and safety; and maintaining project timelines.
- Occasional international or domestic travel to partner and contract facilities as needed. Other duties as assigned.
Minimum Qualification Requirements:
PhD with 5+ years of experience. Equivalent experience may be accepted. Hands on experience in protein purification, including familiarity with process design and scale-up for the following operations: chromatography, tangential flow filtration, membrane filtration, depth filtration, protein refolding, homogenization, and centrifugation. Experience with process analytics including HPLC, SDS-PAGE. Experience with AKTA chromatography systems and software. Must be able to demonstrate hands-on technical proficiency. Able to independently conduct experiments and present work. Ability to work in a fast-paced, goal-oriented environment. Scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development. Excellent written and oral communication skills. Team leadership and managerial experience a plus. Must possess a positive, can-do attitude and demonstrate creative, problem-solving skills. Attention to details and excellent verbal/written communication skills. Flexibility and ability to adapt to quickly changing priorities. Ability to successfully operate while multi-tasking. Demonstrated ability to effectively and collaboratively work in cross-functional teams, meet deadlines, and prioritize multiple activities. Experience in the following areas strongly preferred: experimentation and scale-up of protein refolding, homogenization, and/or centrifugation; protein purification from E. coli or other bacterial fermentations and mammalian expression; tech transfer from lab to clinical manufacturing; working in a GLP or GMP environment; working knowledge of upstream processing/ microbial fermentation; mammalian production; late-stage process development and manufacturing; and process characterization, validation, or commercialization.