Posted on: January 15, 2022
Agenus is an immuno-oncology company designed to deliver
curative cancer therapies for patients through innovation, speed,
and quality. We have a unique portfolio of antibodies, vaccines,
adjuvants and cell therapies (AgenTus Therapeutics subsidiary)
designed to treat cancers using optimal combinations. In addition
to our diverse portfolio, we have an accomplished team of
scientists and engineers, novel technology platforms and end-to-end
capabilities from new target discovery to GMP manufacturing. We
believe that combination therapies based on a deep understanding of
each patient's cancer biology is a key driver for successfully
treating cancer and substantially expanding the patient population
benefiting from immuno-oncology therapies. At Agenus, we believe we
have assembled the capabilities to bring curative cancer treatments
Who are we looking for?
- An Innovative and enthusiastic Scientist/ Senior Scientist with a
strong background in cell based bioassays to join our Analytical
- A candidate who is excited to contribute to novel and impactful
therapeutic approaches and translate scientific discoveries into
- A candidate who loves working on multiple projects in a
What are we looking for?
- Leading the way : Creative and learning-agile, willing to
challenge the status quo
- Ownership : A partner to jointly own our company's goals,
execution, and success
- Working together : A colleague to thrive in collaboration with
our global teammates
What are we offering?
- A dynamic, fun, and learning culture
- Exposure to pioneering science and the full scope of the drug
- Innovative thinking: speed of adopting new technologies, clear
prioritization, using analytics to accelerate agile development
- A team with broad experience and passion about science
- A unique opportunity to help develop the bioassay platforms and
strategy of a burgeoning company
- A broad experience and colleagues who are passionate about
- An extensive research and development portfolio
- Career support and leadership opportunities within Agenus
- Membership within a growing, dynamic and collegial
The Scientist/Senior Scientist will join our Analytical Development
team as a subject matter expert in immunoassays and bioassays. They
will be a key member of Analytical Development responsible for
leading the development and qualification of analytical methods for
monoclonal and bispecific antibodies, establishing robust assays
for evaluation of product potency throughout the various stages of
development and product lifecycle.
In this role, you will be responsible for timely development of
analytical methods supporting their qualification/validation and
transfer to quality control and to external contract organizations
where they will be used in CGMP product testing.
The candidate will design and execute scientific studies and will
collaborate extensively with cross functional Agenus staff and with
representatives from contract manufacturing and testing
- Meet corporate objectives for the development and
qualification/validation of assays implementing technologies such
as ELISA and cell based assays (e.g. gene expression bioassay) to
test and characterize proteins and related compounds.
- Lead support of pharmaceutical products throughout their
lifecycle, such as development samples from Upstream Process
Development and Downstream Purification Development, Formulation
Development, DS and DP Manufacturing.
- Provide scientific input and demonstrate critical thinking into
experimental design and execution, including guidance to address QC
deviations and assist in root cause investigations.
- Write technical development reports and give oral presentations
of data at departmental or interdepartmental meetings.
- Write, review and edit SOPs and Test Methods for new procedures
and assays; review, edit and revise existing SOPs to reflect
changes in procedures.
- Act as analytical subject matter expert and contribute to the
authoring and review of regulatory CMC sections (IND, BLA).
- Maintain lab compliance by performing routine housekeeping,
including support of analytical instrument maintenance, ordering
and stocking of lab supplies, maintaining of reagents, sample
management, and compliance to safety regulations.
- Lead the development, qualification, and transfer of analytical
methods to be used in cGMP QC testing.
- Understanding of ICH guidelines such as "Q6B Specifications: Test
Procedures and Acceptance Criteria for Biotechnological/Biological
Products" and QbD principles described in Q8(R2) Pharmaceutical
- Experience with technologies such as HPLC, CE, and
spectrophotometry to test and characterize proteins and related
compounds (e.g., impurities, post-translational modifications).
- Coordinate with other functional groups to support upstream and
downstream process development studies and have some understanding
and experience with determining critical quality attributes of
Qualifications and Education Requirements
- PhD with 6 years of experience, Masters with 8 years of
experience, or Bachelor's degree in a Scientific field with at
least 10+ years of relevant experience in a development or GMP
environment, especially with protein therapeutics.
- Immunoassay and cell based assay (bioassay) development and
- Skills in Biological/Biochemical/Chemical Sciences, Math and
- Teamwork and communication are key attributes needed for this
position, as this role will be part of a small team. A
collaborative attitude and a positive work ethic are key traits for
- Excellent observation and attention to detail and accuracy for
record keeping and documentation.
- Knowledge of cGMPs.
- Excellent verbal and written communications skills.
- Ability to work independently, and as part of a team on assigned
- Proficiency with Microsoft Word, Excel and PowerPoint software is
required. Knowledge of statistics (i.e. Descriptive, ANOVA, DOE) is
- Prior leadership or project management experience is highly
- Experience in the design, development, and validation of
analytical methods and product characterization for monoclonal
antibody therapeutics is strongly preferred.
- Learning Agility: Capability to think through problems from a
fresh point of view, curiosity and passion for ideas and solving
puzzles, love of learning.
- Detail Orientation: Ability to organize and prioritize many
different important tasks.
- High Execution: Demonstrates and fosters a winning mind set, a
sense of urgency, optimism, and ownership, and a strong drive to
- Collaboration: Demonstrated ability to work cross-functionally,
manage crises and align interests of multiple parties, aptitude for
mastering operational specifics of multiple programs.
- Communication: Excellent written and oral communication skills,
technical writing and presentation skills are essential.
- Flexibility - Ability to adapt to changes, assess priorities and
remain focused on goals.
Keywords: Agenus, Berkeley , Scientist/Senior Scientist, Other , Berkeley, California
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