Operations Lead, Formulation

Description

• Provide Subject Matter expertise on aspects of the Formulation process to enable successful integration of new products and processed into the existing facility.
• Serve as a key integrator for cross-functional teams supporting seamless operation of cGMP production, ensuring readiness of manufacturing areas for start-up, process qualification, and validation activities.
• Support the manufacturing operations team as a key contributor for projects that implement new technologies and operational process improvements in the GMP manufacturing environment, maintaining processing suites in a compliant and validated state.
• Lead or participate in continuous improvement projects, including capacity optimization and cost reduction programs.
• Support the development of the Operational Excellence programs and lead Manufacturing Projects with cross-functional stakeholders.
• Work with cross functional teams to review, author and revise standard operating procedures and batch records, review technical reports, assist with conducting deviation investigations, and write deviation reports.
• Document and communicate all aspects of work and learnings, providing training and mentorship for new personnel.
• Assist with metrics tracking and reporting to leadership teams.
• Support and participate in internal and external regulatory inspections as necessary.

Qualifications

Highest qualification: University

• Bachelor’s Degree in Operations, Business or related field required.
• 5 years of related experience in lieu of Bachelor’s Degree as long as applicant has HS diploma
• Proven experience in project management and coordination.
• Strong analytical skills and proficiency in data analysis tools and techniques.
• Ability to communicate effectively with various audiences.
• Ability to influence networks with multiple levels and functions of the organization.
• Pharmaceutical experience preferred.
• Microsoft Office and Production Planning functional expert required.