Analytical Scientist – Remote
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers has an opening for an experienced Analytical Scientist.
In this remote role, you will be responsible for ensuring our compliance with and adherence to industry expectations for analytical characterization of our lead drug substance. The Associate Analytical Scientist will have a wide range of tasks supporting release and stability testing, analytical validation, process characterization and other program needs related to analytics. Reporting directly to the Director of Analytical Sciences, the Associate Analytical Scientist will have direct involvement and collaboration with the Project Management and Quality groups as part of the CMC team.
Responsibilities include, but are not limited to:
- Technical review of analytical data generated by our external CMOs.
- Compiling data to support process characterization, comparability, and the establishment of specifications.
- Maintenance of Stability programs for drug substance and drug product including review of analytical data and trending of results throughout the studies.
- Collaborating with external labs on analytical validation activities including protocol generation, execution and report review.
- Provide technical support for analytical investigations, deviations, and change controls from external CMOs.
- Identify and implement improvements to existing procedures in alignment with cGMP and regulatory requirements.
- Assuming additional responsibilities as assigned.
Required Skills & Qualifications:
- 5+ years of relevant experience in the biopharmaceutical industry with a preference given to those who have experience in a QC GMP setting.
- Bachelor’s degree or higher in a life sciences, chemistry or engineering field.
- Experience in analytical characterization/testing of monoclonal antibodies through one or more key methodologies (e.g. HPLC/UPLC, CE, ELISA, cell based potency).
- Experience with and demonstrated proficiency in global GxPs.
- Excellent communication skills and ability to provide clear, candid, and transparent descriptions of CMC / technical tasks, issues, schedule challenges, and proposed solutions.
- Results oriented with a demonstrated track record of production related accomplishments.
- Demonstrated ability to enhance cross-functional communication with internal and external teams, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
- Proven history of the ability to work independently and as part of a dynamic team.
- Some travel to US and International sites may be required.
- Must be located within and authorized to work in the United States today and in the future.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to firstname.lastname@example.org and tell us how you’d can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.