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Sr Manager, Process Development
Il y a 3 mois
Strategic
- Build a highly performing team and ensure the right people is at the right place.
- Drive excellence in analytical methods development and validation.
- Raise compliance to regulatory authorities expectations (EMA, FDA) in the field of analytical methods for viral vectors.
- Build a culture of customer centricity within the team and drive customer project to success.
- Identify strategic initiatives or investments with positive impact on department goals and company strategy.
Operational
- Take ownership for the efficient execution of analytical development and validation and optimal management of resources (people, equipment and facilities) within the team.
- Ensure relevant indicators and metrics are in place within the team to monitor compliance to quality standards, training matrix, planning and EHS goals. Take actions to address poor performance or noncompliance.
- Lead, train and mentor team members to raise technical, scientific, regulatory, communication and organizational skills within the team and ensure development of robust analytical methods in line with customers and regulatory authorities' expectations.
- Ensure in depth assessment of analytical methods performance and robustness from development to QC testing. Support the team in the identification of process improvements, investigations or troubleshooting.
- Develop operational planning in collaboration with supply chain and drive schedule optimization by prioritizing resources and customer programs.
- Participate in the budget development, effectively controls expenses (OPEX, CAPEX) within the scope of activities.
- Take responsibility in timely escalating internally or to customers major risks and issues (internal or projectrelated). Assess impact (cost, resources, planning, ) and proactively propose solutions and mitigation plans.
- Take an active role in people development by setting stretch goals, providing meaningful feedback and define individual development path. Identify talents and develop succession plans.
- Maintain uptodate knowledge of viral vectors analytical field (incl. competitive landscape) and provide recommendation regarding investments with benefit on team activities, department goals or company strategy.
- Promote a cooperative climate and enable trusting relationship to deliver department and company objectives. Resolve conflicts in a constructive manner that allows win/win solution
- Promote excellence in execution, rightfirsttime, quality culture and continuous improvement activities within the team.
- Develop, cascade and align personnel with company and site objectives. Ensure appropriate recording and monitoring of individual objectives within the team.
Management
- Direct reports: around 6 senior scientists and managers.
- Total reports: around 25 FTE.
Education and skills
- Master/PhD degree in a life sciences or Chemical Engineering discipline and a minimum of 8 years of relevant experience in analytical methods development, QC testing for biologics, vaccines or cell/gene therapy.
- Expertise in regulatory and cGMP requirements
- Knowledge in biostatistics, upstream, downstream and analytical technologies
- Strong leadership skills and ability to work crossboundaries
- Excellent written and verbal communication skills at all levels in the organization
- Language skills: French and English
