Clinical & Commercial Packaging Engineer

Ocugen, Inc. Malvern , PA 19355

Posted 1 month ago

Job Purpose

The role of Clinical & Commercial Packaging Engineer is responsible for oversight of packaging and logistic suppliers including package and component design, contract compliance, and KPI's associated with Ocugen's various pharmaceutical products in clinical and commercial stages. This position reports directly to the Head of Supply Chain and is part of Ocugen's Manufacturing & Supply Chain team. The successful candidate will thrive in an entrepreneurial environment that is fast passed, fast growth and provides significant opportunities for personal development.

Duties and Responsibilities

  • Source and design clinical and commercial packaging for Ocugen's pharmaceutical drug products

  • Manage vendor contracts and relationships with key suppliers of clinical and commercial packaging sourcing

  • Work cross functionally with Quality, Commercial, Clinical and R&D functions to advance product development timelines

  • Responsible for generation of packaging design, in accordance with regulatory and quality requirements for clinical and commercial drug product

  • Ensure drug product storage conditions are communicated and followed

  • Develop and monitor cold chain logistics for domestic and global supply chain

  • Select, develop, and evaluate suppliers to ensure the efficient operation of the function

  • Oversee packaging operations at contract packagers

Qualifications

  • B.S. degree in engineering or relevant discipline

  • 5+ years of pharmaceutical manufacturing experience, preferably in a manufacturing and/or packaging setting with exposure to serialization, pharmaceutical labeling, cold chain management, and international pharmaceutical supply chains

  • On track to being a subject matter expert in pharmaceutical packaging for both clinical and commercial products

  • Knowledge of applicable quality and regulatory guidelines regarding clinical and commercial packaging

  • Experience working in a GMP regulated environment

  • Strong collaboration and negotiation skills. Motivated self-starter with a passion for patients

  • Detail oriented, exceptional documentation practices, technical writing, and verbal communication skills

  • Excellent problem-solving skills, contingency planning, and risk-mitigation strategies

  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment

Working Conditions

This position will have to travel to vendor sites and relevant meetings as needed

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.

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Clinical & Commercial Packaging Engineer

Ocugen, Inc.