Evelo Biosciences is seeking an experienced and talented Principal Analytical Scientist (Characterization), to join our dynamic organization.
Evelo Biosciences is a fast-paced company discovering drugs based on the previously unexplored biology of the interactions between the gut and the rest of the body: gut-body network. We are developing a new class of medicines that could change the standard of care for many major diseases, providing great benefit to large numbers of patients world-wide. Evelo is advancing a portfolio of medicines, including monoclonal microbials and extracellular vesicles, which use naturally evolved pharmacology to work in the gut for effects throughout the body, providing effective, convenient, safe and cost-effective medicines. As a member of the Evelo team, you will be a vital part of helping to shape Evelo's vision: transforming therapies through this new modality of medicines, to address the unmet needs of huge numbers of patients.
We are seeking a highly motivated, driven and collaborative Principal Analytical Scientist for the Analytical Sciences organization at Evelo Biosciences. The Principal Scientist will lead the development of state-of-the art analytical methods to support comprehensive characterization of the API and drug products. This individual will be accountable for developing the analytical tools required to identify and understand the Critical Quality Attributes for a new class of biologic medicines, which is being advanced to commercialization for the first time. The successful candidate will critically evaluate scientific data and study protocols, take part in and/or lead cross-functional teams, and drive the critical development of our understanding about the key attributes of this new class of product. This is a once-in-a-lifetime opportunity to drive a new modality, ensuring that the product characterization activities are fit-for purpose, and per regulatory requirements.
* Drive and lead complex, state-of the-art method development and qualification to ensure that methods can consistently meet the fit-for-purpose product characterization during late stage of development.
* Lead and participate in product characterization activities to support Evelo pipeline, within established timelines and ensure data quality and integrity.
* Lead cross-functional discussion to plan and execute comprehensive characterization of the products.
* Participate in design and execution of experiments and complete laboratory testing. THis is a lab-based role.
* Follow good documentation and review practices, and effectively communicate scientific results and strategies in presentations and written reports.
* Document/organize/present experimental data, conclusion and other information, including recommendations in a clear, concise and logical manner within function.
* Maintain knowledge of and critically evaluate scientific literature, regulatory requirements and industry trends.
Education and Experience:
* PhD in the biological sciences with min. of 10-year experience in analytical methods development and characterization of large complex biological molecules.
* Previous experience working in late-stage biopharmaceutical development is a must.
* Experience in the field of Microbiology and/or microbiological techniques is preferable.
* Demonstrated contribution leading a group or as an 'individual contributor' towards developing methods, and characterizing products towards successful regulatory filing.
* Proficiency and ability to utilize complex biological techniques and state-of-the-art instrumentation, such as HPLC, MS, GC, spectroscopy, and DLS
* Proven experience with technical writing skills in documentation, preparing technical reports, memos and protocols, including documentation of analytical results in a regulatory compliant manner.
* In-depth working knowledge about ICH and Compendial Guidelines for Bioanalytical methods and product release.
* Possesses exceptional verbal and written communication skills
* Experience with quality systems and electronic lab notebooks.
* Proficient at data analysis and presentation using commercially available software, such as, JMP, Excel, Microsoft PowerPoint etc.
Desired Personal and Business Qualifications:
* Acts decisively and seizes accountability.
* Embraces and leads change.
* Possesses self- awareness.
* Adept at building and developing teams.
* Possesses business acumen. Physical/Travel Requirements:
* Ability to lift to 40 pounds.
* Able to travel to CRO/collaboration sites across the Globe.
* This position requires understanding of biohazard safety guidelines, including wearing PPE.
* Flexibility to accommodate multiple time zones during business.
* Must be available for early morning or evening business conference calls.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing oral biologics that act on SINTAX™, the small intestinal axis, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic and neurological systems. The company's first product candidates are pharmaceutical preparations of single strains of microbes selected for defined pharmacological properties. Evelo's therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.
Evelo currently has four product candidates in development: EDP1815, EDP1867 and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.
For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.
Notice: Roles that take place fully on-site/in office will require Covid-19 vaccination.