Senior Process Engineer
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 is a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers and has an opening for an experienced Senior Process Engineer Process Engineer.
The Senior Process Engineer is part of the CMC team and will be reporting to Director of Process Sciences. The successful candidate is an experienced process engineer with extensive Process Development, Technology Transfer, Manufacturing and Validation experience. This role leverages expertise and knowledge to support and manage the technology transfer and manufacturing of Drug Substance (DS) and Drug Product (DP) at our contract manufacturing organizations (CMO’s).
- You will be responsible for ensuring our manufacturing processes are fit for purpose and that Bulk Drug Substance (BDS) and Drug Product (DP) are manufactured and released through our CMO partners according to phase appropriate GMPs as needed to meet clinical and eventually commercial demand.
- You will also be responsible for assisting with the planning and monitoring of Tech Transfer activities to ensure accurate translation of Process Description requirements into CMO Batch Records and Standard Operating Procedures (SOPs).
- You will provide process support for tech transfer and process scale-up, manufacturing and technical support to facilitate CMO issue resolution, deviation / investigation closure and final product disposition.
- The key to your success will be your ability to work with internal and external groups and push forward to an early BLA for our lead candidate, Seribantumab.
- Participate in the management of technical relationships with CMOs to ensure product manufacturing meets demand needs for Bulk Drug Substance (BDS) and Drug Product (DP) for Elevation Oncology. This will include, but not limited to, act as “Person-in Plant”, Batch Record review and approval, deviation/investigation support and closure and support of final product disposition by Quality Assurance.
- Troubleshoot cell culture (Upstream) and/or purification (Downstream) processes and equipment challenges.
- Support the collaboration and scale-up of Elevation Oncology production processes at our CMO partners to support commercialization.
- Support Process Characterization (PC) activities at our CMO partners. This will include working with the CMO on the development of a comprehensive plan and schedule of process characterization activities.
- Review: CMO process documents, ensuring accuracy of the Process Description; Batch Records and SOPs for alignment with the Process Description; Material Specifications; approval of raw material/consumables procurement plans.
- Work with the CMO team to oversee successful execution of PPQ activities by providing internal process support for tech transfer and process scale-up activities.
- Assist in the preparation of campaign summary reports as required and provide internal review of CMO reports.
- Additional responsibilities as assigned.
Required Skills and Qualifications
BS/MS in Chemical Engineering, Bioscience, Bioengineering or directly related discipline. Additional experience may be substituted for formal education.
Eight (8) to ten (10) years of relevant experience in the biopharmaceutical industry. Including:
- Demonstrated knowledge of cell culture (Upstream) protein processing required. Knowledge of Downstream protein processing strongly preferred.
- Previous experience in a technical role (Process Development, Manufacturing, Validation, etc.)
- Demonstrated problem solving capabilities.
- Experience working with CMO teams to perform root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, CAPAs, etc.)
- Experience in complying with FDA regulatory requirements, including participation in developing and writing documents submitted to the FDA. Familiar with other regulatory agencies as well as authoring CMC sections of submissions is desirable.
- Excellent communication skills and ability to provide clear, candid and transparent descriptions of CMC/technical tasks, issues, schedule challenges and proposed solutions. 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.
- Results oriented with a demonstrated track record of production related accomplishments.
- Must have the ability to build and maintain positive relationships with management, peers and direct reports.
- With two CMO locations in US and one in Korea, potential need to travel (U.S. / Int’l) 25-50% of time.
- Must be located within and authorized to work in the United States today and in the future.
$145,000 – $155,000 annualized
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 can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.