As a Purification Scientist for the Biologics Manufacturing team, you will report to the Senior Scientist and work closely with other scientists in Upstream and Downstream Process Development with the expectation to manage up to one research associate in your team. We are seeking an upbeat candidate with expertise in protein purification with hands-on, in-depth experience purifying monoclonal antibodies, fusion proteins, and bi-specific molecules.
As a Downstream scientist, you will lead internal PD projects where you will be responsible for: developing multi-step purification processes, liquid formulations, authoring development and tech transfer reports, planning, scheduling, and prioritizing workload to meet company goals. You will also be responsible for routing purification of various research molecules in support of internal discovery efforts.
First year goals for this position are:
- Expand in-house Downstream purification process capabilities and take the lead in developing robust processes for large-scale manufacturing of Drug Substance and Drug Product
- Must have management experience advising one or more employees
- Cultivate your teams' skills and career development by mentoring them in basic and sophisticated purification techniques, and lab best-practices
- Knowledge of cIEF/cSDS/Glyco Analytics
- Participate actively in decision-making process on cross-functional project teams by providing scientific input
- Be SME lead for technology transfer of processes for large-scale manufacture of Bulk Drug Substance
- Late Phase III process validation experience a big plus!
- Advance group capabilities and know-how by identifying and implementing novel technologies
- Author Process Descriptions, Purification Processes technical reports, Stability Reports and review draft and executed batch records and manufacturing documents
Ideally looking for candidates with:
- BS or MS with 6+ years industry experience or PhD with at least 4+ years of industry experience. Industry experience is preferred (willing to consider more experience for the right candidate)
- Extensive depth and breadth performing, optimizing, and scaling various purification chromatography techniques: Affinity, SEC, IEX, HIC, mixed mode (e.g. CHT, Capto MMC, Capto Adhere)
- Small and large-scale expertise developing and optimizing process parameters for Tangential Flow Filtration (TFF) and Normal Flow (NF) filtration
- Hands-on experience running analytical assays for protein characterization using the following assays: SEC-HPLC, SDS-PAGE, UV-Vis, LAL
- In-depth experience using AKTA purification systems and familiarity troubleshooting, writing methods, and performing routine maintenance
- Experience with lyophilization of proteins highly desirable
- Familiar with DoE experimental design and statistical interpretation of data using software (e.g., JMP, Stat-Ease) highly desirable
- Proven track record to independently run functional responsibilities
- Leading and mentoring your team
- Excellent written and oral interpersonal skills