9 дней назад
Associate Director - Process Development (Biologics)
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Описание вакансии
Текст:
TL;DR
Associate Director - Process Development (Biologics): Leading biologics process development at the Milton Park facility, including bench-scale experiments, cGMP process characterization, process improvement, and material generation for QC, preclinical, and toxicology studies with an accent on regulatory compliance, documentation, and cross-functional collaboration. Focus on managing the Process Development team, driving continuous improvement in production processes, supporting audits and technology transfer, and ensuring safe, efficient laboratory execution.
Location: Milton Park, United Kingdom; 5 days on-site
Company
develops oncolytic immunotherapies designed to activate durable systemic anti-tumor responses and transform cancer treatment.
What you will do
- Lead the Process Development group at the Milton Park facility and provide regular activity updates to senior management.
- Plan, execute, and oversee bench-scale experiments supporting characterization and improvement of cGMP production processes.
- Ensure laboratory work follows experimental designs, SOPs, protocols, batch records, and safety requirements.
- Produce materials for QC and analytical assay controls, preclinical studies, and toxicology studies.
- Author and review reports, protocols, SOPs, batch records, laboratory records, and technical documentation.
- Represent Process Development in site leadership meetings, audits, cross-functional work, and technology transfer activities.
Requirements
- Bachelor’s degree in an applicable field; an advanced degree is preferred.
- At least 10 years of experience with a bachelor’s degree, or 6–8 years with an MS or PhD, in biologics process development or manufacturing.
- Thorough understanding of current regulatory requirements and practical experience supporting cGMP operations.
- Proven experience leading, managing, and motivating team members.
- Ability to collaborate effectively with management, project teams, and other functional groups.
- Excellent verbal and written communication skills.
Culture & Benefits
- Work is performed on-site at the Milton Park facility, typically five days per week.
- Safety-focused working environment with adherence to established procedures and guidelines.
- Opportunity to contribute to cancer therapies and work across UK and US Process Development teams.
- Some domestic and international travel may be required.
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