11 часов назад
Senior Process Development Scientist (Materials Attributes and Technologies)
146 000 - 189 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Process Development Scientist (Materials Attributes and Technologies) (Biologics Manufacturing): Developing control strategies and evaluating single-use materials for commercial biologics manufacturing with an accent on material suitability, compatibility, robustness, and cGMP process performance. Focus on leading material risk assessments, process characterization and validation, troubleshooting material issues, and introducing alternative process technologies.
Location: Framingham, United States; on-site
Salary: $146,000–$189,000 annually, plus performance incentive bonus, new-hire equity, and ongoing performance-based equity.
Company
is a biotechnology company developing oncolytic immunotherapies designed to activate durable systemic anti-tumor responses and transform cancer treatment.
What you will do
- Serve as a subject matter expert on single-use processing materials, including plastics, glass, and related technologies.
- Evaluate material suitability, compatibility, robustness, and risks affecting supplies, processes, products, and customers.
- Support manufacturing through technical reviews of change controls, deviations, CAPAs, supplier notifications, and material-related troubleshooting.
- Build a material trending program to monitor performance, quality attributes, and process shifts.
- Lead process characterization experiments and process validation activities for drug substance and drug product production.
- Collaborate with QC Analytical on extractables and leachables testing, contribute to process improvements and new technology introduction, support audits, and author regulatory filing sections.
Requirements
- Bachelor’s degree in a relevant field; an advanced degree is preferred.
- At least 2 years of experience in materials science, preferably in biologics process development or manufacturing support.
- Experience with single-use manufacturing materials and technologies, including plastics and glass.
- Experience with ultra-low cold-chain insulation materials and development.
- Ability to work effectively across cross-functional teams with strong organization, attention to detail, and written and oral communication skills.
- Ability to follow safety procedures and provide technical representation during internal and external audits.
Culture & Benefits
- Purpose-driven work focused on improving outcomes for cancer patients and caregivers.
- Collaborative, bold, dedicated, and candid working environment.
- Medical, dental, and vision insurance.
- 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
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