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 of many major diseases for the great benefit of large numbers of patients world-wide. These medicines are designed to act on the gut-body network – monoclonal microbials. They are single strains of human commensal microbes which use naturally evolved pharmacology to work in the gut for effects throughout the body, providing effective, convenient and safe medicines to address the unmet needs of huge numbers of patients.
As a member of the Evelo team, you will be a vital part of helping to shape Evelo’s vision: transforming therapies through a new modality of medicines. We are seeking a highly motivated, driven and collaborative Lead QC Manager for our Analytical Sciences Dept within the Technical Operations organization at Evelo Biosciences. The QC Manager will develop, lead and manage laboratory quality system. The candidate will have shared accountability of Evelo Biosciences’ product release and stability data review.
The successful candidate will critically evaluate scientific data and study protocols, will lead initiatives, and take part in, and lead cross-functional teams. In addition, this individual will be a stakeholder in ensuring that analytical methods and data are fit-for-purpose.
- Lead and participate in activities to support Evelo pipeline within established timelines and ensure data quality and integrity.
- Perform laboratory quality system gap analysis and address them in timely manner.
- Participate in cross-site method qualification/validation activities to ensure that methods can consistently meet quality requirements.
- Drive and perform timely review of complete release testing and stability data for the drug substance and drug product batches produced at CMO sites.
- Participate in lab audits and lab investigations related to OOS & other deviations along with QA colleagues.
- Follow good documentation and review practices, and effectively communicate scientific results and strategies in presentations and written reports.
- Maintain knowledge of and critically evaluate quality and compendial literature and industry trends.
Education and Experience:
- MS in the biological sciences with a minimum of 10-year experience in development and quality control laboratories with expertise or familiarity in arrays of bioanalytical methods used for small and/or large molecules including biologicals.
- Previous experience in the biopharmaceuticals industry is a must.
- Lead a group, as needed, towards qualifying & validating methods, and reviewing release/stability data towards successful regulatory filing.
- Experience in Microbiology and microbiological techniques would be a big plus.
- Proven experience with technical writing skills to draft documentation, preparing technical reports, memos and protocols.
- In-depth working knowledge about ICH and Global compendial guidelines for bioanalytical method qualification and validation and product release.
- Possesses exceptional verbal and written communication skills.
- Experience with quality systems and electronic lab notebooks desirable.
- Proficient at data analysis and presentation using commercially available software, such as, Excel, Microsoft PowerPoint etc. Desired Personal and Business Qualifications:
- Acts decisively and seizes accountability
- Holds team members accountable
- Embraces and leads change • Possesses self- awareness
- Adept at building and developing teams
- Possesses business acumen Physical/Travel Requirements:
- Able to travel to vendor/CMO sites across the Globe for several weeks
- This position requires understanding of aseptic technique and biohazard safety guideline including wearing PPE.
- Flexibility to accommodate multiple time zones as needed.
- Must be available for early morning or evening business calls