Join Our Team
Intera Oncology is dedicated to substantially improving the survival of colorectal cancer and cholangiocarcinoma patients through hepatic arterial infusion.
Intera Oncology is looking for medical device professionals who are entrepreneurial in approach and committed to the mission of delivering lifesaving products to help cancer patients.
We are passionate about innovation in cancer therapy and we seek team members who share our enthusiasm and interest.
We are a team of experienced professionals from the business, medical device, and therapeutic fields. We are looking for alike individuals who want to make a large impact on a start up’s trajectory.
Teachnical Operations Lead
The Technical Operations Lead is responsible for ensuring that technical aspects of projects and supply chain are managed in collaboration with internal team members and contract manufacturers (CMO). This position will work with service providers to verify that products/processes are compliant with company and regulatory quality standards. The Technical Operations Lead will independently manage multiple projects or phase(s) of a larger project and build relationships with internal and external resources to ensure seamless transition of the project(s) as they progress from tech transfer/qualification to commercialization.
Education and Experience
- Represent Intera Oncology as the technical interface with CMOs and logistics in order to maintain supply chain and technical transfer of manufacturing processes
- Perform technical review of internal and CMO project documents (tech transfer documents, development/process characterization/process validation plans, production/test records, summary reports)
- Attend and/or lead internal and CMO project meetings
- Coordinate with internal and external resources to ensure smooth manufacturing operations
- Provide leadership on technical strategy and execution from project initiation through scale up, tech transfer, during routine manufacturing and related to sustaining engineering.
- Provide technical assessment on project change controls and deviations
- Perform equivalency assessments/gap analyses during tech transfer activities and sustain engineering projects including sourcing new supplier and new materials as needed. Evaluate changes and work with the CMO and Intera Regulatory Affairs to implement such changes.
- Oversee and coordinate production schedules to ensure build plans meet sales demand including supervising internal resources as needed.]
- Work closely with Regulatory Affairs and Quality to provide documentation in support of regulatory submissions
Knowledge, Skills, Abilities
- B.S in engineering, or equivalent technical field and 3-5 years of experience
- Demonstrated manufacturing technical support experience
- Experience in research & development and program management a plus
- Expert in understanding design control requirements
- A sound understanding of medical device production and scale-up principles, process validation, including EO sterilization, and regulatory strategies a must
- Willing to be an individual contributor while also leading teams and managing others
- Strong documentation practices, organizational skills, and attention to detail
- Strong verbal and written communication skills
- Excellent interpersonal skills
- Strong decision-making and problem-solving skills
- Ability to effectively prioritize and execute tasks in a fast-paced environment
- Proficient in Microsoft Office program suite
- Experience working in a start-up environment a plus
- Familiarity with project management knowledge and skills a plus
- Knowledge of FDA, EU, and other relevant regulatory environments is a plus
Send resume and cover letter to email@example.com.
Please no calls or recruiters