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Scientist/Senior Scientist

Company: Agenus
Location: Berkeley
Posted on: January 15, 2022

Job Description:

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 to patients.

Who are we looking for?
- An Innovative and enthusiastic Scientist/ Senior Scientist with a strong background in cell based bioassays to join our Analytical Development team.
- A candidate who is excited to contribute to novel and impactful therapeutic approaches and translate scientific discoveries into cancer therapies.
- A candidate who loves working on multiple projects in a fast-paced environment

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 development process
- 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 science
- An extensive research and development portfolio
- Career support and leadership opportunities within Agenus
- Membership within a growing, dynamic and collegial organization

Job Responsibilities
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 organizations.

Responsibilities

Required:
- 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.

Preferred:
- 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 Development.
- 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 protein therapeutics.

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 validation.
- Skills in Biological/Biochemical/Chemical Sciences, Math and English.
- 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 success.
- 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 projects.
- Proficiency with Microsoft Word, Excel and PowerPoint software is required. Knowledge of statistics (i.e. Descriptive, ANOVA, DOE) is desirable.

Preferred Skills:
- Prior leadership or project management experience is highly desirable.
- Experience in the design, development, and validation of analytical methods and product characterization for monoclonal antibody therapeutics is strongly preferred.

Competencies:
- 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 achieve goals.
- 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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