5 дней назад
MSAT Downstream Process Scientist I (Biologics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MSAT Downstream Process Scientist I (Biologics): Supporting technology transfer, commercial manufacturing, and process improvement for biologics in a GMP manufacturing environment with an accent on process understanding, technical documentation, and manufacturing data analysis. Focus on leading process support, investigating deviations and root causes, assessing product quality, and ensuring cGMP and regulatory compliance.
Location: Portsmouth, New Hampshire, USA; fully site-based. On-call rotation is required after sufficient training.
Company
operates globally connected manufacturing sites supporting the development and production of life-science therapies.
What you will do
- Serve as a technical lead for technology transfer and commercial manufacturing process support.
- Develop process understanding, perform risk assessments, and support process improvement initiatives.
- Author and review process descriptions, batch records, change controls, and other technical documentation.
- Monitor manufacturing performance, analyze process data, and communicate findings to stakeholders.
- Support deviation investigations, root cause analysis, product quality assessments, lot release, and regulatory compliance.
- Represent MSAT on customer-facing and internal project teams, audits, and operational meetings.
Requirements
- Bachelor’s degree in Biological Sciences, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
- Experience supporting manufacturing processes, technology transfer, or process development.
- Knowledge of GMP-regulated manufacturing environments.
- Strong analytical, problem-solving, and data interpretation skills.
- Experience authoring and reviewing technical documentation.
- Effective communication and collaboration skills across cross-functional teams.
Nice to have
- Master’s degree or PhD.
Culture & Benefits
- Collaborative, agile, and inclusive working environment.
- Opportunities to support innovative biologics manufacturing programs and customer-facing projects.
- Professional development and technical growth opportunities.
- Medical, dental, and vision insurance.
- Compensation programs recognizing high performance.
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