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)
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
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
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
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
Familiarity with Design of Experiment (DOE) and comfortable
working with analytical tools to create high-quality unbiased
Prior experience with a successful technology and process
transfers to third party vendors (CRO/CDMO/CMO) is highly
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
Familiarity or experience with scripting and statistical
analysis of your data.
Experience collaborating with computational scientists while
analyzing your data.