Principal Analytical Scientist
Company: Evelo Biosciences
Posted on: June 25, 2022
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. Primary Responsibilities:
- 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
- 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
- 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
- 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
- In-depth working knowledge about ICH and Compendial Guidelines
for Bioanalytical methods and product release.
- Possesses exceptional verbal and written communication
- Experience with quality systems and electronic lab
- 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
- This position requires understanding of biohazard safety
guidelines, including wearing PPE.
- Flexibility to accommodate multiple time zones during
- Must be available for early morning or evening business
conference calls.About Evelo BiosciencesEvelo 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.
Keywords: Evelo Biosciences, Cambridge , Principal Analytical Scientist, Other , Cambridge, Massachusetts
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