6 дней назад
Technical Operations Senior Engineer (Oncolytic Virus Manufacturing)
146 000 - 189 000$
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Описание вакансии
Текст:
TL;DR
Technical Operations Senior Engineer (Oncolytic Virus Manufacturing): Providing technical support and lifecycle management for commercial oncolytic virus manufacturing processes with an accent on technology transfer, process validation, and regulated biologics operations. Focus on troubleshooting manufacturing equipment, optimizing processes, analyzing continuous process verification data, and leading risk assessments and change execution.
Location: Framingham, Massachusetts, United States; 5-day on-site expectation
Salary: $146,000–$189,000 annual base pay
Company
is a biotechnology company developing oncolytic immunotherapies based on its proprietary HSV-1 platform to activate systemic anti-tumor immune responses.
What you will do
- Provide technical support and cross-functional leadership for oncolytic virus drug substance, drug product, and secondary packaging manufacturing.
- Manage technology transfer, post-transfer manufacturing support, commercialization, process validation, and manufacturing readiness activities.
- Troubleshoot product processing technologies and equipment, including bioreactors, TFF systems, chromatography systems, and filling machines.
- Lead CAPA, change control, deviation resolution, continuous process verification, and process improvement activities.
- Conduct process optimization, data and trend evaluation, risk assessments, and mitigation planning.
- Author technical documentation and support regulatory filings, audits, supplier changes, and cross-functional manufacturing execution.
Requirements
- Master’s degree in chemical or biomedical engineering with 4–6 years of related experience, or bachelor’s degree with 6–8 years of related experience.
- At least 4 years of experience in biologics drug substance or drug product process development or manufacturing support.
- Experience with single-use manufacturing technologies, manufacturing equipment troubleshooting, and commercial manufacturing in a regulated environment.
- Experience with process characterization, Process Performance Qualification, Continued Process Verification, commercialization, and process validation lifecycle activities.
- Experience using FMEA, risk analysis, and change impact assessment methods.
- Strong technical writing, data analysis, communication, organizational, and cross-functional collaboration skills.
Culture & Benefits
- Purpose-driven work focused on transforming cancer treatment and improving patient outcomes.
- Medical, dental, and vision insurance.
- 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
- Eligibility for an annual performance incentive bonus, new-hire equity, and ongoing performance-based equity.
- Commitment to safe work practices, technical development, and an inclusive equal-opportunity workplace.
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