Hybrid Sr. Director Technical Operations chez OCUGEN OPCO INC

Description

Job Purpose

The purpose of this role is to provide in-plant leadership for manufacturing at Ocugen and provide technical expertise and leadership to Ocugen's external manufacturing partners. This role's primary responsibility is to shape the tactical implementation of Ocugen's focus on internal manufacturing for cell and gene therapies. 

Responsibilities The Sr. Director Technical Operations will ensure that our manufacturing processes are compliant, cost-efficient, and state of the art. The Sr. Director Technical Operations will lead a team of experts, collaborate and drive innovation in biologics manufacturing platforms to support Ocugen’s evolving product portfolio.  This role will directly manage validation, sterility assurance, and manufacturing to effectively deliver clinical and commercial supplies.  Specific responsibilities include, but are not limited to the following:

• Establish and lead cell and gene therapy manufacturing teams to ensure efficient, predictable, and GMP compliant product delivery.
• Ensure efficient startup, commissioning, and qualification of Ocugen’s cell and gene therapy manufacturing facility located in Malvern PA. 
• Lead technology transfers, define and implement biologics platform strategies, and drive lifecycle improvements for our gene and cell therapy portfolio.
• Develop and industrialize Ocugen’s gene and cell therapy platforms utilizing digital tools and modeling to optimize processes and performance.
• Provide technical support, troubleshoot issues, and resolve challenges related to biologics manufacturing.
• Effectively collaborate with CMC, Quality, and development teams, external partners, and cross-functional stakeholders to achieve shared goals.
• Establish and lead initiatives to improve product robustness, manufacturing performance, and subject matter expertise across the network.
• Lead and resolve product investigations as required.
• Review, edit, or produce regulatory documentation as required.

Qualifications

• Advanced scientific qualifications (BSc, MSc, or PhD) in chemical engineering, pharmacy, biochemistry, or a related field.
• 15+ years of experience, including leading technical teams across multiple geographies.
• Expertise in biologics manufacturing platforms, technical transfers, process improvement, and compliance with US FDA, EMEA, and APAC regulatory requirements.
• Working knowledge of digital solutions and their application in biologics manufacturing.
• Exceptional leadership, communication, and interpersonal skills.
• Demonstrated success in leading organizations to readiness for filing BLAs/ MAAs and extensive experience with domestic and international inspections to 21 CFR 210, 211, 1271 as well as EU GMP Guidelines (Directive 2003/94/EC), Annex 1, and EC No. 1394/2007.
• Must have broad expertise in manufacturing processes including gene therapy, cell therapy and aseptic processes, including sterile fill/finish.
• Skilled in preparation of CMC modules of regulatory filings such as INDs, IMPDs, and BLAs.
• Extensive experience managing global CDMOs and/or third-party manufacturers and testing labs.
• Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment