Manager, Ocular Health Pilot Plant Operation

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking for a Manager of Ocular Health Pilot Plant Operation in Fort Worth, TX. The Manager of Ocular Health Pilot Plant Operation, reporting to the Director of Formulation-Material-Process Development, is crucial to ensuring the efficient, compliant development, qualification, and operation of aseptic processes and pilot production activities. As the company continues to innovate and scale, it requires a highly skilled leader to manage both pilot operations and team performance within an environment governed by stringent regulatory standards and quality requirements. This role is vital for maintaining operational excellence, effectively managing risk, and driving continuous improvement across aseptic production, process qualification, and pilot operations.

The Manager of Ocular Health Pilot Plant Operation will lead a small, elite team in the areas of aseptic process qualification, pilot equipment validation, and production operations. The ideal candidate will have a strong technical background, a hands-on approach to aseptic process qualifications and equipment management, and the leadership ability to oversee a team in a fast-paced, dynamic environment. This role will be responsible for the establishment and continuous improvement of our aseptic program and infrastructure to support product development while ensuring compliance with industry standard, efficiency, readiness for audits, and maintaining compliance with industry standards.

In this role, a typical day will include:

Aseptic Program and Aseptic Process Qualification:

• Lead and conduct hands-on qualification of aseptic processes and pilot equipment calibration for new and existing products, ensuring accurate performance.

• Develop and implement best practices for process and equipment qualification, ensuring compliance with industry standards and contamination control strategies.

• Oversee and collaborate with the Aseptic Program SMEs in the establishment and continuous improvement of the aseptic program, ensuring compliance with both internal and external regulations.

Pilot Operations & Maintenance Oversight:

• Oversee and collaborate with the Pilot Line SMEs in the setup and operation of pilot lines, ensuring proper maintenance, troubleshooting, and continuous improvement of equipment reliability.

• Develop and implement preventive maintenance plans for pilot equipment as well as the operation and qualification of pilot suites and utilities.

Pilot Production Oversight:

• Collaborate with the pilot production lead to manage pilot production at lab and pilot scales to support product development and business needs, ensuring smooth operations and optimization.

• Lead troubleshooting efforts, improve scalability, and improve production infrastructure.

• Actively participate in aseptic production, ensuring operations meet quality and compliance standards.

Risk Assessment and Non-Conformance Investigation:

• Conduct risk assessments for aseptic processes, pilot production, and equipment, implementing mitigation strategies as needed.

• Lead non-conformance investigations, perform root cause analysis, and implement corrective and preventive actions (CAPA) in line with regulatory and GMP standards.

Operational Systems Improvement and Quality Compliance:

• Collaborate with the Operations Systems Lead to enhance operational efficiency, simplify processes, and ensure audit readiness and compliance.

• Partner with the Quality team to ensure all activities comply with GMP, SOPs, and regulatory requirements, driving system improvements and continuous quality assurance.

Team Management:

• Manage a small team of full-time employees and contractors, providing leadership, guidance, and development opportunities to align with organizational goals.

• Set clear expectations, drive accountability, and serve as a role model with can-do attitude and strong attention to detail.

• Manage relationships with external vendors and contractors to ensure timely delivery of materials and services, maintaining compliance with company standards and regulatory requirements.

Experience:

• A Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Life Sciences, Biotechnology, or a related field, with 10+ years of experience in aseptic manufacturing, specializing in validation, non-conformance investigations, and quality assurance within the pharmaceutical or biopharmaceutical industry.

• Extensive hands-on experience in managing processes, troubleshooting, and ensuring the successful, timely delivery of results.

• Strong analytical abilities to assess complex situations, identify key issues, and implement practical solutions.

• Expertise in addressing issues directly and efficiently, with a focus on delivering pragmatic solutions that drive results.

• In-depth knowledge of Good Manufacturing Practices (GMP), aseptic techniques, process validation, and risk management.

• Comprehensive experience with regulatory standards, including FDA, EMA, and other industry-specific guidelines.

• Ability to quickly adapt to changes, demonstrating resilience and maintaining a positive attitude while staying focused on achieving results.

What You'll Bring to Alcon:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

• The ability to fluently read, write, understand, and communicate in English

• 5 Years of Relevant Experience

How You Can Thrive at Alcon:

• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

• Travel Requirements: 0-5%

• Relocation assistance: No

• Sponsorship available: No

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.