Downstream Process Development Scientist

Company: Bevov
Location: Pleasanton
Posted on: November 13, 2020

Job Description:

Position Overview We're looking for an excellent Downstream and Purification Process Development Scientist to join our client's dynamic team in South San Francisco. This role is an exciting opportunity to lead the development of formulations for building novel exosome therapeutics. Responsibilities Lead downstream purification process development for exosome therapeutic development programs, currently in the preclinical stage.

Develop FPLC-based scalable column chromatographic methods for the purification and isolation of high-quality exosome products, including, but not limited to, preparatory scale affinity purification, ion exchange (IEX) chromatography, multimodal, hydrophobic interaction, and size exclusion (SEC) chromatography.

Execute and improve current Tangential Flow Filtration (TFF) procedure for isolation and formulation of exosome products.

As a subject matter expert, maintain knowledge and implement state-of-the-art technologies and processes for exosome purification and isolation.

Author process descriptions, SOPs, protocols, and tech transfer documents necessary for seamless process transfer to internal or external collaborators.

Meticulously maintain complete and accurate records of all work performed in LIMS and/or electronic lab notebook (ELN).

Play a central role in selection and interaction with contract manufacturers/research organizations, key suppliers, and other external vendors. Prior experience working with and managing CMO/CDMO/CRO desired.

Manage the downstream process development function, including operational considerations, lab buildout and equipment purchases, team recruitment, and training, setting key metrics and objectives, and providing guidance and mentorship to junior staff.

Coordinate tasks across multiple projects, demonstrating prioritization and planning. We are a start-up and are looking for applicants who are ready and willing to ‘roll their sleeves up’ and be the Key Driver to meet project timelines and milestones.

Qualification and Skills BS/MS degree with 6+ experience or Ph.D. degree with 3+ years of experience in a drug development setting.

4+ years of biologics downstream process development experience using a FPLC system (e.g. AKTA)

Expertise in method/protocol development and scale-up for biologics purification, including, but not limited to affinity, cation exchange (CEX), anion exchange (AEX), viral filtration, and tangential flow filtration (TFF) is required.

Familiarity with HPLC based analytical methods (SEC, RP-HPLC, ion-exchange, hydrophobic interaction chromatography, etc)

Prior experience with IND regulatory requirements, GMP environments, and quality documentation is highly desired.

Demonstrated ability to work independently with minimal supervision.

Familiarity with Design of Experiment (DOE) and comfortable working with analytical tools to create high-quality unbiased analyses.

Prior experience with a successful technology and process transfers to third party vendors (CRO/CDMO/CMO) is highly desired.

Experience mentoring, coaching, and training junior staff members are preferred.

Excellent interpersonal skills, including clear, succinct, and timely communication and proven ability to foster strong relationships with other team members and stakeholders.

Highly self-motivated and detail-oriented, with proven ability to work in a dynamic, fast-moving team.

Comfortable working with a data-driven team and collaborating with research scientists, data scientists, and platform engineers.

Familiarity or experience with scripting and statistical analysis of your data.

Experience collaborating with computational scientists while analyzing your data.

Keywords: Bevov, Pleasanton , Downstream Process Development Scientist, Other , Pleasanton, California