|Date Posted||November 18, 2020|
|Address||726 Heartland Trail, Suite 100|
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Job Title: Director, Lab Operations
Reports to: Vice President, Global Regulatory Affairs and Compliance
Location: Remote position
The Lab Operations Director is the business process owner for the development of global, harmonized processes for enterprise lab automation systems and the implementation and post-implementation support across the Catalent Business Units and sites. Key responsibilities include providing overall Quality function leadership for global lab processes and establishing and defining the user requirements for deployment of the lab automation solutions. A key focus is continual improvement to support the growth of the business, improve operating efficiencies and influence decisions regarding business process changes and capital investments of laboratory systems and equipment.
- Analyze current and future lab related processes & requirements and assist the development of business cases that increase efficiency and compliance via the enabler IT solutions and laboratory technology.
- Works closely with the functional leadership, site personnel and IT organizations to develop standardized global business processes.
- Serves as the business process lead on the cross-functional implementation teams that are responsible for the configuration, testing, and validation of lab automation solutions along with system deployment activities. Works within and across the BU Quality Function to define standard work practices and solutions where feasible.
- Provides key project support to lab automation end users during system development, implementation, testing and maintenance, including the preparation of appropriate project and validation documentation.
- Assures that proper User Requirement Specifications (URS) are established for each of the enterprise lab automation system to support local and enterprise-wide business processes. Supports vendor selection and quality audits.
- Ensures that deployed systems comply with all applicable GxP, legal, and fiduciary policies, practices and requirements.
- Accountable for lab automation program delivery communications, organizational change management activities and project deliverables. Communicates on project related activities to the sponsor, operating committee, steering committee and other program stakeholders.
- Leads and influences the analysis of new technology solutions, enhancements to existing solutions, functionality of lab automation systems, new business processes & operating models for laboratories across the network, new laboratory equipment investments and operational readiness assessments.
- Bachelor’s or Master’s Degree in Computer Science, Business Administration, or other Science related field.
- 10+ years’ experience in leading pharmaceutical laboratories and supporting enterprise lab automation projects. 5+ years of leadership responsibility managing cross functional teams and influencing senior-level management and key stakeholders.
- 5+ years’ experience in implementing LIMS (e.g., LabVantage) and (e.g., Empower) Chromatography solutions in a global environment.
- Experience leading microbiological and analytical laboratories is preferred.
- Travel of approximately 25%.
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops