The Vice President of Global MSAT will lead the Global MSAT team, overseeing Tech Transfer, Technology, Automation, Validation, and Modeling. Reporting to the Senior Vice President of Manufacturing Operations, this role encompasses directing the design, implementation, and maintenance of the J.POD manufacturing platform across the Just-Evotec Biologics global network.
Responsibilities:
- Responsible for the development and implementation of the J.POD manufacturing platform, including upstream and downstream integrated continuous process and equipment, single-use technologies, and process automation.
- Oversees the Tech Transfer Team which is responsible for late stage/ commercial technology transfer, including PPQ campaign support.
- Oversees the Technology Team responsible for evaluating, designing, and implementing manufacturing process equipment and single-use technologies.
- Oversees the Automation Team which is responsible for design and applications in process digital systems, including the Process Automation System, the Manufacturing Execution System, and process data management systems.
- Provides oversight for the Validation Team which is responsible for establishing programs and standards for the network, and for developing and executing validation protocols for the manufacturing facilities, utilities, process and analytical equipment, and process validation.
- Provides oversight for the Modeling Team which is a center of excellence for data science and business analysis expertise, providing support to process engineering and development teams, and supporting decision-making around manufacturing cost and capacity.
- Responsible for ensuring manufacturing process network alignment through platform strategy documents, business process, and governance.
- Collaborates with multiple organizations, including manufacturing, QA/QC, process development, business development, supply chain, and QA/QC teams.
- Supports business development through client interactions.
- Creates vision and a roadmap for the current and future direction of the J.POD manufacturing platform and drives teams to deliver and execute on new manufacturing processes and technologies.
- Represent the company externally at scientific conferences through speakership and conference leadership positions.
Position Requirements:
- B.S. or higher degree in chemical or biological engineering, life science or related program with 20+ years relevant experience.
- Extensive knowledge and experience with biologics drug substance manufacturing processes, including both upstream and downstream processing technologies, continuous processing, and single-use technologies.
- Demonstrated leadership experience as head of an MSAT organization.
- Recognized expert in the field of manufacturing sciences, including technology transfer, scale-up, process risk assessments, process modeling, process monitoring, and validation.
- Demonstrated capabilities to build and mentor high performing teams, drive change, and influence internal and external stakeholders.
- Previous experience as project lead for a major capital project, and/or a process or tech transfer project team lead, especially for a late stage/ commercial program.
- Significant experience with process risk assessment tools (e.g. FMEA) and facilitating risk assessments, regulatory CMC documents and responses to health authority questions, and providing audit and inspection support.
- Experience with process modeling tools and software.
- Working knowledge of equipment software and automation systems, unit operation recipes and methods for all upstream and downstream systems.
- Considered a thought leader in the global scientific community, and established in the field through external presentations, papers, and conference leadership positions.
- Proven knowledge of cGMP requirements.
- Good interpersonal, team, and collaborative skills are required.
- Excellent oral and written communication skills.
Additional Preferred Qualifications:
- Leadership of global teams, Center of Excellence, etc.
- Working knowledge of DeltaV automation systems and Manufacturing Execution Systems.
- Experience authoring BLA or MAA documents, and direct support of regulatory agency interactions, including Type C meetings and PAIs.
The base pay range for this position at commencement of employment is expected to be $225,000 to $255,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include 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.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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