About the Company:
Dren Bio (the “Company”) is a privately held, pre-clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company’s management team and scientific advisors have profound expertise covering the discovery and development of engineered antibodies designed to selectively target and deplete pathological cells. Dren Bio’s pipeline is currently comprised of two distinct programs. The first program surrounds DR-01, the Company’s lead product candidate, which induces antibody-mediated killing of a cell type that is responsible for a multitude of hematologic malignancies and plays a key role in various autoimmune diseases. The Company’s second program is a proprietary antibody-based technology platform, its Targeted Myeloid Engager, which utilizes a novel mechanism of action to selectively engage myeloid cells for the targeted depletion of diseased cells and disease-inducing agents, as well as to induce immunostimulation.
Analytical and Formulation Development and Drug Product Manufacturing
Senior Scientist I
Redwood City, CA
Director, Analytical and Formulation Development
About the Opportunity:
Dren Bio is seeking a highly motivated individual to support antibody characterization and formulation development for the Company’s pipeline programs. The successful candidate will work as a bench Scientist to conduct analytical method and formulation development and be involved in interactions with contract development and manufacturing organizations (CDMOs). This position offers excellent potential for contribution and visibility at an early-stage company and opportunities for career development.
Role and Responsibilities:
Develop HPLC, capillary electrophoresis and ELISA based analytical methods for protein/antibody characterization.
Serve as investigative lead on antibody/bispecific programs with respect to analytical methods (including but not limited to RP-HPLC, Ion exchange, Capillary electrophoresis, SE-HPLC and HIC).
Apply scientific principles, current technologies, and personal experience to design and execute appropriate experiments to solve a given problem.
Work closely with colleagues in Process Sciences group to ensure timely analytical support for cell line, process, and formulation development.
Partner with discovery/biology groups to establish process and criteria for manufacturability assessments for clinical candidates at discovery stage.
Contribute to authoring/reviewing CMC sections in IND/CTA submissions and BLA/MAA submissions; includes developing comparability strategies and performing CQA assessments.
Facilitate the development of SOPs for various analytical methods and the qualification of methods required for technical transfer to CDMO/CRO facilities.
Maintain and troubleshoot analytical instrumentation as required and troubleshoot assay performance as needed.
Supervise and mentor junior staff with analytical development activities when appropriate.
Independently evaluate literature to identify and implement new analytical tools and methodologies as part of continuous improvement.
Document experimental work in notebooks, SOPs and reports.
Communicate results and provide updates at internal and external project team meetings.
Education, Experience and Qualification Requirements:
PhD in Biochemistry, Analytical Chemistry or related discipline with approximately 5+ years of experience in the biotechnology industry.
Core Competencies, Knowledge and Skill Requirements:
Hands-on knowledge of technical scientific principles for most of the following analytical techniques: HPLC/UPLC (reverse phase, ion exchange, size exclusion), capillary electrophoresis; working knowledge of LC/MS is highly desirable.
Strong analytical and critical thinking skills with the ability to interpret complex data and highly motivated to learn and support the drug development efforts.
Ability to manage and mentor junior staff in method development work; previous supervisory experience preferred.
Experience with performing developability or manufacturability assessments for therapeutic candidates is desirable.
Motivated self-starter who can work independently and collaboratively in a dynamic team environment with a proactive attitude.
Excellent written and verbal communication skills.
Ability to work in a fast-paced environment and the flexibility to align daily work with project needs.
Ability to set goals and prioritize tasks and resources to achieve superior work quality and efficiency.
Must be well organized, have a strong work ethic, attention to detail and be diligent in data documentation.
Salaries, Benefits and Other Employee Perks:
Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. Exact cash and equity compensation shall be commensurate with candidate’s experience and qualifications.
Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law..
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