Associate Director/Director of Process Sciences
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 Associate Director / Director of Process Sciences.
In this role, 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. Planning and oversight of Tech Transfer activities to ensure accurate translation of Process Description requirements into CMO Batch Records and SOPs will also be a primary focus. You’ll have a huge impact as you play a key role in developing and implementing a QbD system to enhance process and analytical knowledge; 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. 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.
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
Acting as primary process liaison to CMOs to ensure product manufacturing meets demand needs for BDS and DP. This will include Person-in-Plant, Executed Batch Record review and issue resolution, deviation / investigation support and closure, and support of final product disposition by QA.
Leading the collaboration and scale-up of Elevation Oncology production processes at our CMO partners to support commercialization. Oversee and ensure success of process characterization activities at CMO partners. This will include working with the CMO on development of a comprehensive plan and schedule of process characterization activities.
Reviewing CMO process documents, ensuring accuracy of the Process Description, reviewing of Batch Records and SOPs for alignment with the Process Description, reviewing Material Specifications, reviewing and approving raw material / consumables procurement plans.
In collaboration with QA, you will be the Process Validation lead overseeing, providing technical oversight of process and equipment changes at the CMO and participating in evaluation of proposed change controls related to technical issues.
Assisting with the development and implementation of a QbD system to further process understanding for ELV’s products, facilitating trending and assessment of process parameters and quality attributes in order to set operational limits, specifications, and ultimately design space as products progress to BLA.
Working with the CMO and ELV CMC management develop a PPQ plan. Work with the CMO team to oversee successful execution of PPQ activities
Providing internal process support for TT and process scale-up activities.
Be the internal Lead in development and oversight of hands-on process optimization and scale-up experiments. Collaborating with CMO Process Development in process scale-up efforts to go from small scale to intermediate and/or large scale to support commercial product.
Assisting in preparation of campaign summary reports as required and provide internal review of CMO reports.
Assuming additional responsibilities as assigned.
Lead process characterization
REQUIRED SKILLS & QUALIFICATIONS:
7-15+ years of relevant experience in the biopharmaceutical industry.
BS / MS in Biosciences, Bioengineering or applicable discipline (Hands-on experience may be a partial substitute for formal education).
Experience in technical / process development and process characterization and validation, with a primary focus on biologics.
Experience with and demonstrated proficiency in global GxPs.
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.).
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.
Familiar with current issues and Regulatory requirements related to manufacturing using stainless steel and single use equipment for drug substance and drug product production.
Experience with preparation of reports suitable for regulatory filing.
Proven history of the ability to work independently and as part of a dynamic team.
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