Analyst joining global Quoting Operations team at Tanium, supporting complex quotes and renewals, ensuring deal accuracy and compliance.
About the role
- Senior Vice President overseeing global manufacturing operations at Evotec, shaping strategy and ensuring operational excellence. Leading teams and driving compliance in biologics manufacturing.
Responsibilities
- Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectives
- Develop/Build a scalable manufacturing organization to meet the corporate goals
- Provide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future challenges
- Foster a culture of quality and compliance throughout the organization
- Manage site performance, ensuring operational excellence;
- Review and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirements;
- Plan staff and equipment operations scheduling;
- Successfully execute advanced biologics manufacturing technologies;
- Troubleshoot and/or provide technical expertise to perform or lead investigations;
- Assist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systems;
- Provide support for regulatory and site inspections,
- Manage OPEX and CAPEX budgets; develop a culture of continuous improvement;
- Incorporate and expand sustainability into manufacturing operations;
- Build and develop staff for future roles and career progression;
- Ensure a culture of safety.
Requirements
- PhD or Master’s degree in biological or engineering science with 15+ years relevant experience or
- Bachelor’s degree in biological or engineering science with 20+ years relevant experience
- Extensive experience in late-stage/commercial biologics drug substance manufacturing
- Technical mastery of cell culture and purification operations at commercial scale
- Proven knowledge of cGMP requirements to ensure compliance
- Advanced skills in the operation of single-use technologies, including cell culture, purification and drug substance filling operations
- Validation experience, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
- Strong understanding of process automation (e.g. DeltaV) and BAS systems
- Experienced in the use of electronic systems such as QMS, MES/EBR, CMMS, and ERP systems
- Previous experience managing the activities of individuals, work groups, and project teams.
- Possess strong focus on quality and attention to detail
- Possess effective task/time management organizational skills
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills are a must
- Excellent oral and written communication skills
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off and paid holiday
- wellness and transportation benefits
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